Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-04-22 @ 11:31 AM
Study NCT ID:
NCT02408835
Status:
UNKNOWN
Last Update Posted:
2015-04-06
First Post:
2014-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Negative Pressure Wound Therapy in Groin Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D008207', 'term': 'Lymphatic Metastasis'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-03', 'studyFirstSubmitDate': '2014-12-19', 'studyFirstSubmitQcDate': '2015-04-03', 'lastUpdatePostDateStruct': {'date': '2015-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to wound healing', 'timeFrame': 'From date of surgery until epithelial integrity is restored at the surgical site. Assessed at least weekly until wound is healed, up to 20 weeks after surgery', 'description': 'Determination of wound healing'}], 'secondaryOutcomes': [{'measure': 'Wound infection As defined by Comprehensive Complication Index (CCI)', 'timeFrame': 'From date of surgery until wound is healed (epithelial integrity restored at surgical site), up to 20 weeks after surgery.', 'description': 'As defined by Comprehensive Complication Index (CCI)'}, {'measure': 'Lymphoedema (Limb volume measurements)', 'timeFrame': 'From date of surgery up to one year post-operatively.', 'description': 'Limb volume measurements at 3, 6, 9 and 12 months'}, {'measure': 'Need for further surgical interventions to achieve wound healing', 'timeFrame': 'From date of surgery until wound is healed, up to 20 weeks after surgery.'}, {'measure': 'Scar appearance (POSAS)', 'timeFrame': 'From date of surgery up to one year post-operatively.', 'description': 'POSAS at 3,6, 9 and 12 months'}, {'measure': 'Patient reported outcomes (qualitative interview)', 'timeFrame': 'From date of surgery to six months post-operatively.', 'description': 'Semi-structured qualitative interviews in first week after surgery, and at 6 months after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['negative pressure wound therapy', 'lymphadenectomy', 'wound healing'], 'conditions': ['Neoplasm Metastasis', 'Secondary Malignant Neoplasm of Lymph Node', 'Non-healing Surgical Wound (Disorder)', 'Skin Neoplasms']}, 'descriptionModule': {'briefSummary': 'This study investigates the use of a negative pressure wound therapy device (PICO™, Smith \\& Nephew Healthcare, UK) on clean, closed surgical wounds, in patients who are undergoing inguinal lymphadenectomy for metastatic carcinoma of cutaneous origin.', 'detailedDescription': 'Patients may develop inguinal lymph node metastases from a variety of cutaneous neoplasms. A number of factors conspire to cause a high rate of wound breakdown and other complications in this patient group. Reported rates of wound healing complications vary in the literature, but tend to affect \\> 40% of patients.\n\nA new negative pressure wound therapy device is recommended for use in clean, closed surgical wounds (PICO™ system, Smith \\& Nephew Healthcare, UK). Patients will be randomised to receive either PICO™ system for up to seven days, or conventional dressings, and then assessed for wound healing and other outcome measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically- or cytologically-proven inguinal lymph node metastases from neoplasm of cutaneous origin\n\nExclusion Criteria:\n\n* inability to give informed consent for participation'}, 'identificationModule': {'nctId': 'NCT02408835', 'briefTitle': 'Negative Pressure Wound Therapy in Groin Dissection', 'organization': {'class': 'OTHER', 'fullName': 'South Eastern Health and Social Care Trust'}, 'officialTitle': 'A Randomised Controlled Trial Comparing PICO™ Single Use Negative Pressure Wound Therapy System (Smith & Nephew Healthcare Limited, UK) to Conventional Wound Care Following Inguinal Lymphadenectomy for Metastatic Cutaneous Malignancy', 'orgStudyIdInfo': {'id': 'NPWT/14/1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PICO™', 'description': 'Use of PICO™ system negative pressure wound therapy device on surgical wound for up to seven days.', 'interventionNames': ['Device: PICO™']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional wound care', 'description': 'Usual wound dressings will be used as comparison group.'}], 'interventions': [{'name': 'PICO™', 'type': 'DEVICE', 'otherNames': ['PICO™, Smith & Nephew Healthcare, UK'], 'description': 'Negative pressure wound therapy device for closed surgical wounds.', 'armGroupLabels': ['PICO™']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT16 1RH', 'city': 'Belfast', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'contacts': [{'name': 'Sandra E McAllister, MD', 'role': 'CONTACT', 'email': 's.mcallister@qub.ac.uk', 'phone': '+442890484511'}, {'name': 'Christopher Hill, MB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Ulster Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}], 'centralContacts': [{'name': 'Sandra E McAllister, MD', 'role': 'CONTACT', 'email': 's.mcallister@qub.ac.uk', 'phone': '02890484511'}, {'name': 'Christopher Hill, MB', 'role': 'CONTACT', 'phone': '02890484511'}], 'overallOfficials': [{'name': 'Christopher Hill, MB', 'role': 'STUDY_CHAIR', 'affiliation': 'South Eastern Health & Social Care Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Eastern Health and Social Care Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Academic Clinical Lecturer', 'investigatorFullName': 'Sandra McAllister', 'investigatorAffiliation': 'South Eastern Health and Social Care Trust'}}}}