Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-08 @ 8:27 AM
Study NCT ID:
NCT01640366
Status:
COMPLETED
Last Update Posted:
2020-02-28
First Post:
2012-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PICO Breast Reduction Clinical Study Looking at Incision Healing Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rachael.winter@smith-nephew.com', 'phone': '+44 1482 673475', 'title': 'Rachael Winter, Director of Clinical Operations', 'organization': 'Smith & Nephew Inc'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'There was one site (68 enrolled participants in total) in which the data were analyzed separately due to issues at the site. This data was also analyzed and included in the overall totals for baseline characteristics and outcome measures.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline through 90 days postoperatively.', 'eventGroups': [{'id': 'EG000', 'title': 'PICO Negative Pressure Wound Therapy', 'description': 'PICO: Single-use Negative Pressure Wound Therapy system (su-NPWT)', 'otherNumAtRisk': 200, 'deathsNumAtRisk': 200, 'otherNumAffected': 50, 'seriousNumAtRisk': 200, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Standard of Care Dressing Arm', 'description': 'Adhesive Skin Closure Strips, e.g. STERI-Strips, or alternatively a non-adherent dry dressing if Adhesive Skin Closure Strips was not deemed appropriate by the Principle Investigator at that center.', 'otherNumAtRisk': 200, 'deathsNumAtRisk': 200, 'otherNumAffected': 70, 'seriousNumAtRisk': 200, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Delayed wound healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 50, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 70, 'numAffected': 70}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Epidermolysis at T-junction/skin trifurcation point', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Fat necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Infection and dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Severe postoperative pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO Negative Pressure Wound Therapy/Standard of Care Dressing', 'description': 'PICO (single-use Negative Pressure Wound Therapy system \\[su-NPWT\\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.'}], 'classes': [{'title': 'PICO treatment with healing complications', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}]}]}, {'title': 'PICO treatment without healing complications', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': 'Standard care with healing complications', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}]}]}, {'title': 'Standard care without healing complications', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21 days postoperatively', 'description': 'The primary variable of whether or not the incision developed a healing complication within 21 days of surgery was defined as the presence of at least one of the following:\n\n1. Infection (superficial or deep),\n2. Dehiscence (partial, superficial or deep),\n3. Delayed healing (defined as incision not closed within 7 days of the first surgical procedure).\n\nAll participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO Negative Pressure Wound Therapy', 'description': 'PICO: Single-use Negative Pressure Wound Therapy system (su-NPWT)'}], 'classes': [{'title': 'PICO treatment with wound dehiscence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'PICO treatment without wound dehiscence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '165', 'groupId': 'OG000'}]}]}, {'title': 'Standard care with wound dehiscence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Standard care without wound dehiscence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21 days postoperatively', 'description': "Assessment of the number of participants' incisions that experienced dehiscence (superficial, partial, or deep) occurring up to and 21 days postoperatively between incisions treated with PICO compared with standard care dressings.\n\nAll participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results at this time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO Negative Pressure Wound Therapy/Standard of Care Dressing', 'description': 'PICO (single-use Negative Pressure Wound Therapy system \\[su-NPWT\\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.'}], 'classes': [{'title': 'PICO treatment with wound infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'PICO treatment without wound infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}]}]}, {'title': 'Standard care with wound infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Standard care without wound infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21 days postoperatively', 'description': "Assessment of the number of participants' incisions that experienced an infection (superficial or deep) occurring up to and 21 days postoperatively between incisions treated with PICO compared with standard care dressings.\n\nAll participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results at this time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO Negative Pressure Wound Therapy/Standard of Care Dressing', 'description': 'PICO (single-use Negative Pressure Wound Therapy system \\[su-NPWT\\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.'}], 'classes': [{'title': 'PICO treatment with delayed healing', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}]}]}, {'title': 'PICO treatment without delayed healing', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}, {'title': 'Standard care with delayed healing', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}]}]}, {'title': 'Standard care without delayed healing', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days postoperatively', 'description': "Assessment of the number of participants' incisions that experienced delayed healing within 7 days of surgery between incisions treated with PICO compared with standard care dressings.\n\nAll participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO Negative Pressure Wound Therapy/Standard of Care Dressing', 'description': 'PICO (single-use Negative Pressure Wound Therapy system \\[su-NPWT\\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.'}], 'classes': [{'title': 'PICO treatment with delayed healing', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'PICO treatment without delayed healing', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}]}]}, {'title': 'Standard care with delayed healing', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'Standard care without delayed healing', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 10 days postoperatively', 'description': "Assessment of the number of participants' incisions that experienced delayed healing within 10 days of surgery between incisions treated with PICO compared with standard care dressings.\n\nAll participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery.'}, {'type': 'SECONDARY', 'title': 'Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO Negative Pressure Wound Therapy/Standard of Care Dressing', 'description': 'PICO (single-use Negative Pressure Wound Therapy system \\[su-NPWT\\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.'}], 'classes': [{'title': 'PICO - VAS Global Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '9'}]}]}, {'title': 'Standard care - VAS Global Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '8'}]}]}, {'title': 'PICO - POSAS Observer Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '41'}]}]}, {'title': 'Standard care - POSAS Observer Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '44'}]}]}, {'title': 'PICO - POSAS Patient Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '51'}]}]}, {'title': 'Standard care - POSAS Patient Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '90 days postoperatively', 'description': "Assessment of the Patient and Observer Scar Assessment Scale (POSAS) and the Visual Analogue Scale (VAS) between postsurgical incisions treated with PICO compared with standard care dressings.\n\nVAS score: Assessed for color, appearance, contour, distortion, and texture. Each score ranged from 5 to 18; 5 being 'excellent' and 18 being 'poor.' Also, a global scar score was included in the total score.\n\nPOSAS score: Scored in 2 parts which added to create a total score, observer score and patient score. The lowest score of 1 showed 'normal' skin and the highest score of 10 showed the 'worst imaginable' result.\n\nObserver score = 6 categories (vascularity, pigmentation, thickness, relief, pliability, and surface area) each given a score of 1-10.\n\nPatient score = 6 categories (scar pain, itching, color, stiffness, thickness, and irregularity each given a score of 1-10.\n\nAll participants received both PICO and standard care dressings simultaneously during the course of the study.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results at the 90 day time point.'}, {'type': 'SECONDARY', 'title': 'Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO Negative Pressure Wound Therapy/Standard of Care Dressing', 'description': 'PICO (single-use Negative Pressure Wound Therapy system \\[su-NPWT\\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.'}], 'classes': [{'title': 'PICO - skin necrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Standard care - skin necrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'PICO - nipple and areola necrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Standard care - nipple and areola necrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '21 days postoperatively', 'description': 'The nipple and areola areas were not covered by the PICO or standard care dressing as part of the evaluation, they were all dressed the same with Steri-strips and dry gauze pads, which was essentially the standard care dressing regime.\n\nAll participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results for this time point.'}, {'type': 'SECONDARY', 'title': "Number of Hematoma's Occurring up to and 21 Days Postoperatively", 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO Negative Pressure Wound Therapy/Standard of Care Dressing', 'description': 'PICO (single-use Negative Pressure Wound Therapy system \\[su-NPWT\\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.'}], 'classes': [{'title': 'PICO - hematoma occurred', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Standard care - hematoma occurred', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '21 days postoperatively', 'description': 'Assessment of participants developing a hematoma up to 21 days postoperatively for incisions treated with PICO compared with standard care dressings.\n\nAll participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results for this time point.'}, {'type': 'SECONDARY', 'title': 'Number of Wounds Showing 100% Closure Occurring up to and 21 Days Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PICO Negative Pressure Wound Therapy/Standard of Care Dressing', 'description': 'PICO (single-use Negative Pressure Wound Therapy system \\[su-NPWT\\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.'}], 'classes': [{'title': 'PICO - 100% wound closure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}]}]}, {'title': 'Standard care - 100% wound closure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '21 days postoperatively', 'description': 'Assessment of wound appearance demonstrating 100% wound closure at 21 days postoperatively for both PICO treatment and standard of care treatment.\n\nAll participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results for this time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PICO Negative Pressure Wound Therapy/Standard of Care Dressing', 'description': 'PICO (single-use Negative Pressure Wound Therapy system \\[su-NPWT\\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}]}, {'type': 'Day 21 Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '185'}]}, {'type': 'Day 42 Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}]}, {'type': 'Day 90 Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'There were 200 participants enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PICO Negative Pressure Wound Therapy/Standard of Care Dressing', 'description': 'PICO (single-use Negative Pressure Wound Therapy system \\[su-NPWT\\]) or standard of care dressing (sterile gauze adhesive strips) were randomized to either breast following bilateral breast reduction surgery for concomitant treatment to assess the aesthetic appearance and quality of resultant scar.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '199', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '199', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'groupId': 'BG000', 'lowerLimit': '18.1', 'upperLimit': '57.3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Administration of Prophylactic Antibiotics', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '188', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Surgical Technique', 'classes': [{'title': 'Superior pedicle', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Inferior pedicle (with inverted "T" incision)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}, {'title': 'Superior and inferior pedicle', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Superior pedicle and superomedial', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Surgery', 'classes': [{'categories': [{'measurements': [{'value': '168.3', 'groupId': 'BG000', 'lowerLimit': '49', 'upperLimit': '445'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Mean Tissue Resection Weight', 'classes': [{'title': '< 500 g', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}, {'title': '500 - <1000 g', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}]}]}, {'title': '1000 - <1500 g', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}, {'title': '> 1500 g', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '200 participants were enrolled, but 1 subject never attended any follow-up visits and was thus excluded from all data.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2012-07-03', 'resultsFirstSubmitDate': '2017-01-20', 'studyFirstSubmitQcDate': '2012-07-12', 'lastUpdatePostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-13', 'studyFirstPostDateStruct': {'date': '2012-07-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively', 'timeFrame': '21 days postoperatively', 'description': 'The primary variable of whether or not the incision developed a healing complication within 21 days of surgery was defined as the presence of at least one of the following:\n\n1. Infection (superficial or deep),\n2. Dehiscence (partial, superficial or deep),\n3. Delayed healing (defined as incision not closed within 7 days of the first surgical procedure).\n\nAll participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively', 'timeFrame': '21 days postoperatively', 'description': "Assessment of the number of participants' incisions that experienced dehiscence (superficial, partial, or deep) occurring up to and 21 days postoperatively between incisions treated with PICO compared with standard care dressings.\n\nAll participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO."}, {'measure': 'Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively', 'timeFrame': '21 days postoperatively', 'description': "Assessment of the number of participants' incisions that experienced an infection (superficial or deep) occurring up to and 21 days postoperatively between incisions treated with PICO compared with standard care dressings.\n\nAll participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO."}, {'measure': 'Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively', 'timeFrame': 'Within 7 days postoperatively', 'description': "Assessment of the number of participants' incisions that experienced delayed healing within 7 days of surgery between incisions treated with PICO compared with standard care dressings.\n\nAll participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO."}, {'measure': 'Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively', 'timeFrame': 'Within 10 days postoperatively', 'description': "Assessment of the number of participants' incisions that experienced delayed healing within 10 days of surgery between incisions treated with PICO compared with standard care dressings.\n\nAll participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO."}, {'measure': 'Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively', 'timeFrame': '90 days postoperatively', 'description': "Assessment of the Patient and Observer Scar Assessment Scale (POSAS) and the Visual Analogue Scale (VAS) between postsurgical incisions treated with PICO compared with standard care dressings.\n\nVAS score: Assessed for color, appearance, contour, distortion, and texture. Each score ranged from 5 to 18; 5 being 'excellent' and 18 being 'poor.' Also, a global scar score was included in the total score.\n\nPOSAS score: Scored in 2 parts which added to create a total score, observer score and patient score. The lowest score of 1 showed 'normal' skin and the highest score of 10 showed the 'worst imaginable' result.\n\nObserver score = 6 categories (vascularity, pigmentation, thickness, relief, pliability, and surface area) each given a score of 1-10.\n\nPatient score = 6 categories (scar pain, itching, color, stiffness, thickness, and irregularity each given a score of 1-10.\n\nAll participants received both PICO and standard care dressings simultaneously during the course of the study."}, {'measure': 'Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively', 'timeFrame': '21 days postoperatively', 'description': 'The nipple and areola areas were not covered by the PICO or standard care dressing as part of the evaluation, they were all dressed the same with Steri-strips and dry gauze pads, which was essentially the standard care dressing regime.\n\nAll participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.'}, {'measure': "Number of Hematoma's Occurring up to and 21 Days Postoperatively", 'timeFrame': '21 days postoperatively', 'description': 'Assessment of participants developing a hematoma up to 21 days postoperatively for incisions treated with PICO compared with standard care dressings.\n\nAll participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.'}, {'measure': 'Number of Wounds Showing 100% Closure Occurring up to and 21 Days Postoperatively', 'timeFrame': '21 days postoperatively', 'description': 'Assessment of wound appearance demonstrating 100% wound closure at 21 days postoperatively for both PICO treatment and standard of care treatment.\n\nAll participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['surgical incision', 'reduction mammoplasty', 'healing complications', 'negative pressure wound therapy'], 'conditions': ['Delayed Healing']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if the use of a single-use negative pressure wound therapy system (NPWT) will have an effect on the reduction of post-surgical incision healing complications following breast reduction surgery and to assess the medium-term aesthetic appearance and quality of the resultant scar, compared with standard of care dressings.', 'detailedDescription': 'The aim of the present study is to assess the efficacy and cost-effectiveness of the Single-Use Negative Pressure Wound Therapy (NPWT) system (PICO) with regard to the reduction of postsurgical incision healing complications during the immediate postoperative treatment phase, and to assess the medium-term aesthetic appearance and quality of the resultant scar, in patients undergoing reduction mammoplasty, compared to standard care.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female patient's ≥ 18 years old\n* The patient is able to understand the trial and is willing to consent to the trial\n* Patient has undergone an elective surgical procedure for bilateral reduction mammoplasty\n* Patients postsurgical incisions are of similar length\n\nExclusion Criteria:\n\n* Pregnant or lactating females\n* Patients on steroids or other immune modulators known to impact healing which may affect scar appearance\n* Patients with tattoos in the area of the incisions\n* Patients with skin conditions (Cutis laxa etc.) that would result in poor healing or widened scars\n* Patients with a known significant history of scar problems i.e. hypertrophic scaring or keloids\n* Patients who in the opinion of the investigator may not complete the study for any reason\n* Patients with a known history of poor compliance with medical treatment\n* Patients who have participated in this trial previously and who were withdrawn\n* Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing)\n* Incisions that are actively bleeding\n* Exposure of blood vessels, organs, bone or tendon at the base of the reference wound\n* Incisions \\> 12 inches (30cm) max linear dimension"}, 'identificationModule': {'nctId': 'NCT01640366', 'briefTitle': 'PICO Breast Reduction Clinical Study Looking at Incision Healing Complications', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'A Prospective, Randomized, Intra-patient, Comparative, Open, Multi-centre Study to Evaluate the Efficacy of a Single-Use NPWT System on the Prevention of Incision Healing Complications in Patients Undergoing Reduction Mammoplasty', 'orgStudyIdInfo': {'id': 'CE/US/11/01/PIC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PICO negative pressure', 'description': 'Single-use Negative Pressure Wound Therapy', 'interventionNames': ['Device: PICO']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care dressing arm', 'description': 'Sterile gauze adhesive strips'}], 'interventions': [{'name': 'PICO', 'type': 'DEVICE', 'otherNames': ['Disposable NPWT'], 'description': 'Single-use Negative Pressure Wound Therapy System', 'armGroupLabels': ['PICO negative pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes Hôtel Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '6202', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis Maastricht (AZM)', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'University of Cape Town', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}], 'overallOfficials': [{'name': 'Robert D Galiano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University Feinberg School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}