Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-28 @ 2:07 PM
Study NCT ID:
NCT01286168
Status:
COMPLETED
Last Update Posted:
2014-12-19
First Post:
2011-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Degnim.Amy@mayo.edu', 'phone': '507-284-6357', 'title': 'Dr. Amy C. Degnim', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Eligible subjects were recruited prospectively from the breast surgical practices between May 2011 and June 2013.', 'description': 'All subjects underwent a mandatory follow-up visit approximately one week after surgery, at which time surgical sites are evaluated and appropriate study cultures obtained. Additional visits were made for clinical care; follow up phone calls were also made to the subjects.', 'eventGroups': [{'id': 'EG000', 'title': 'Antisepsis Side', 'description': "A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days. The drainage bulb will be irrigated with 10ml of 0.125% sodium hypochlorite (Dakin's solution) twice a day.\n\nSodium hypochlorite (Dakin's Solution): 10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day\n\nChlorhexidine gluconate disk: Apply one chlorhexidine disk to the intervention drain site(s) and change every three days\n\nOcclusive Adhesive Dressing: A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days.", 'otherNumAtRisk': 104, 'otherNumAffected': 3, 'seriousNumAtRisk': 104, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Side', 'description': 'Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care.\n\nControl: Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care.', 'otherNumAtRisk': 104, 'otherNumAffected': 6, 'seriousNumAtRisk': 104, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Surgical Site Infection', 'notes': 'Surgical site infection per operated side within one year of operation. Includes only infections that occurred before a secondary operation such as tissue expander/implant exchange.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entire Study Population', 'description': 'Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.'}], 'classes': [{'title': 'Antisepsis Side', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Control Side', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Antisepsis and Control sides were compared.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 1 week after surgery', 'description': 'Bacterial growth was defined as plate growth of 1+ or greater. Drains were removed at variable times across patients, per clinical indication. When clinically indicated, some patients did have their drains removed at the one week visit, in which case they only had one bulb fluid culture.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was modified intent-to-treat (IIT); subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Drain Tubing Colonization at Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entire Study Population', 'description': 'Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.'}], 'classes': [{'title': 'Antisepsis Side', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Control Side', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Antisepsis and Control sides were compared.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately two weeks after surgery', 'description': 'Drain tubing colonization was defined as greater than 50 colony forming units. Drains were removed at variable timepoints based on the clinical situation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was modified intent-to-treat; subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis. 2 subjects missed endpoint due of protocol deviation or discontinuation, and 2 had the sterility of their drain tubing compromised by external exposures.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entire Study Population', 'description': 'Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.'}], 'classes': [{'title': 'Antisepsis Side', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Control Side', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000'], 'groupDescription': 'Antisepsis and Control sides were compared.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 2 weeks after surgery', 'description': 'Bacterial growth was defined as plate growth of 1+ or greater. Drains were removed a variable times across patients, per clinical indication. A second bulb culture was obtained later than 1 week ONLY in those drains that were not removed at 1 week.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was modified intent-to-treat (IIT). Reported here only in those subjects where drain removal was later than primary endpoint collection.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Surgical Site Infection Within 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entire Study Population', 'description': 'Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.'}], 'classes': [{'title': 'Antisepsis Side', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Control Side', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Antisepsis and Control sides were compared.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 30 days after surgery', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was modified intent-to-treat (IIT); subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Surgical Site Infection Within 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entire Study Population', 'description': 'Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.'}], 'classes': [{'title': 'Antisepsis Side', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Control Side', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.45', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Antisepsis and Control sides were compared.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately one year after surgery', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}, {'units': 'drains', 'counts': [{'value': '317', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entire Study Population', 'description': 'Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.'}], 'classes': [{'title': 'Antisepsis side n=157 drains', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Control side n=160 drains', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Antisepsis and Control sides were compared. Unadjusted p-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.02', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Antisepsis and Control sides were compared. P-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient. P-value was adjusted for side- and drain-specific variables: indication (cancer or prophylaxis), operation (mastectomy only, mastectomy+SLNB, mastectomy +ALND), and drain duration.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 1 week after surgery', 'unitOfMeasure': 'drains', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'drains', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Analysis was modified intent-to-treat (IIT); subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Per Drain Analysis: Drain Tubing Colonization at Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}, {'units': 'drains', 'counts': [{'value': '305', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entire Study Population', 'description': 'Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.'}], 'classes': [{'title': 'Antisepsis side, n=151 drains', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Control side, n=154', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000'], 'groupDescription': 'Antisepsis and Control sides were compared. Due to zero events in the antisepsis side for this endpoint, p-value was derived from likelihood-ratio test comparing the intercept only model to the model with intercept and treatment side included.', 'statisticalMethod': 'Likelihood-ratio test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately one month after surgery', 'unitOfMeasure': 'drains', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'drains', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Analysis was modified intent-to-treat; subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis. 2 subjects missed endpoint due of protocol deviation or discontinuation, and 2 had the sterility of their drain tubing compromised by external exposures.'}, {'type': 'SECONDARY', 'title': 'Per Drain Analysis: Drain Bulb Fluid Colonization at Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}, {'units': 'drains', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entire Study Population', 'description': 'Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.'}], 'classes': [{'title': 'Antisepsis side, n=85 drains', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Control side, n=88 drains', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000'], 'groupDescription': 'Antisepsis and Control sides were compared. Unadjusted p-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000'], 'groupDescription': 'Antisepsis and Control sides were compared. P-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient. P-value was adjusted for side- and drain-specific variables: indication (cancer or prophylaxis), operation (mastectomy only, mastectomy+SLNB, mastectomy +ALND), and drain duration.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately one month after surgery', 'unitOfMeasure': 'drains', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'drains', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Analysis was modified intent-to-treat (IIT). Reported here only in those subjects where drain removal was later than primary endpoint collection.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Entire Study Population', 'description': 'Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Surgical Drains Fell Out at Home', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This study was conducted at the Mayo Clinic, Rochester, Minnesota, and the University of California, San Francisco, California. Eligible subjects were recruited prospectively from the breast surgical practices between May 2011 and June 2013.', 'preAssignmentDetails': "Six subjects did not start study therapy: One subject became a screen failure when her procedure was changed to a lumpectomy. For one subject, no Dakin's solution was available at the pharmacy. Four subjects withdrew, changing their minds about participating."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '67'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '104', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '23.8', 'groupId': 'BG000', 'lowerLimit': '17', 'upperLimit': '45.1'}]}]}], 'paramType': 'MEDIAN', 'description': "Body Mass Index (BMI) is a health index for comparing weight to height. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared. The body mass index is an indication if a person is at a suitable weight for his height on an approximation of body fat. A body mass index of under 20 is considered to be underweight, while a body mass index between 20 to 25 is considered healthy. A body mass index in the range of 25 to 30 is regarded as overweight. A body mass index over 30 is regarded as obese.", 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'American Society of Anesthesiologists (ASA) Class', 'classes': [{'title': 'Class I', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Class II', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}]}]}, {'title': 'Class III', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The ASA physical status classification system is a system for assessing the fitness of cases before surgery. Class 1: Healthy person. Class 2: Mild systemic disease. Class 3: Severe systemic disease. Class 4: Severe systemic disease that is a constant threat to life. Class 5: A moribund person who is not expected to survive without the operation. Class 6: A declared brain-dead person whose organs are being removed for donor purposes.', 'unitOfMeasure': 'participants'}, {'title': 'Operative Time', 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'BG000', 'lowerLimit': '2.9', 'upperLimit': '9.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'hours', 'dispersionType': 'FULL_RANGE'}, {'title': 'Smoking within 4 weeks preoperation', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diagnosis of diabetes', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Neoadjuvant chemotherapy', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Indication for surgery', 'classes': [{'title': 'Unilateral cancer with CPM', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}]}]}, {'title': 'Bilateral prophylactic mastectomy', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': 'Bilateral cancer', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Contralateral prophylactic mastectomy (CPM)', 'unitOfMeasure': 'participants'}, {'title': 'Type of Preoperative Antibiotic', 'classes': [{'title': 'Cefazolin', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}]}]}, {'title': 'Clindamycin', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Levofloxacin', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Vancomycin', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type of Operation (Antisepsis side)', 'classes': [{'title': 'Mastectomy only', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}, {'title': 'Mastectomy + sentinel lymph node biopsy (SLNB)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}, {'title': 'Mastectomy + axillary lymph node dissection (ALND)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type of Operation (Control Side)', 'classes': [{'title': 'Mastectomy only', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}, {'title': 'Mastectomy + sentinel lymph node biopsy (SLNB)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}, {'title': 'Mastectomy + axillary lymph node dissection (ALND)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type of Mastectomy (Antisepsis Side)', 'classes': [{'title': 'Skin-sparing', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}, {'title': 'Nipple-sparing', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type of Mastectomy (Control Side)', 'classes': [{'title': 'Skin-sparing', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}, {'title': 'Nipple-sparing', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Indication for Mastectomy (Antisepsis Side)', 'classes': [{'title': 'Cancer', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}, {'title': 'Risk-reducing', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Indication for Mastectomy (Control Side)', 'classes': [{'title': 'Cancer', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}, {'title': 'Risk-reducing', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of Drains (Antisepsis Side)', 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of Drains (Control Side)', 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type of Reconstruction (Antisepsis Side)', 'classes': [{'title': 'Tissue expander', 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}]}]}, {'title': 'Direct-to-implant', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type of Reconstruction (Control Side)', 'classes': [{'title': 'Tissue expander', 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}]}]}, {'title': 'Direct-to-implant', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Acellular dermal matrix used (Antisepsis Side)', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Acellular dermal matrix used (Control Side)', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Intraoperative Fill Volume (Antisepsis Side)', 'classes': [{'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '800'}]}]}], 'paramType': 'MEDIAN', 'description': 'Interoperative fill volume available in n=101 participants, and missing in n=3 participants.', 'unitOfMeasure': 'mL', 'dispersionType': 'FULL_RANGE'}, {'title': 'Intraoperative Fill Volume (Control Side)', 'classes': [{'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '800'}]}]}], 'paramType': 'MEDIAN', 'description': 'Interoperative fill volume available in n=101 participants, and missing in n=3 participants.', 'unitOfMeasure': 'mL', 'dispersionType': 'FULL_RANGE'}, {'title': 'Number of Lymph Nodes Removed (Antisepsis Side)', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '33'}]}]}], 'paramType': 'MEDIAN', 'description': 'Among sides with either sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND), n=46 antisepsis side.', 'unitOfMeasure': 'lymph nodes', 'dispersionType': 'FULL_RANGE'}, {'title': 'Number of Lymph Nodes Removed (Control Side)', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '36'}]}]}], 'paramType': 'MEDIAN', 'description': 'Among sides with either SLNB or ALND, n=43 control.', 'unitOfMeasure': 'lymph nodes', 'dispersionType': 'FULL_RANGE'}, {'title': 'Maximum Drain Duration (Antisepsis Side)', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000', 'lowerLimit': '6', 'upperLimit': '50'}]}]}], 'paramType': 'MEDIAN', 'description': 'Maximum duration across all drains on a given side.', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}, {'title': 'Maximum Drain Duration (Control Side)', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000', 'lowerLimit': '6', 'upperLimit': '34'}]}]}], 'paramType': 'MEDIAN', 'description': 'Maximum duration across all drains on a given side.', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}, {'title': 'Adjuvant Radiation Therapy (Antisepsis Side)', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Adjuvant radiation therapy within one year, but prior to tissue expander exchange.', 'unitOfMeasure': 'participants'}, {'title': 'Adjuvant Radiation Therapy (Control Side)', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Adjuvant radiation therapy within one year, but prior to tissue expander exchange.', 'unitOfMeasure': 'participants'}], 'populationDescription': 'This number includes all subjects who started study therapy.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-03', 'studyFirstSubmitDate': '2011-01-26', 'resultsFirstSubmitDate': '2014-10-13', 'studyFirstSubmitQcDate': '2011-01-27', 'lastUpdatePostDateStruct': {'date': '2014-12-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-13', 'studyFirstPostDateStruct': {'date': '2011-01-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week', 'timeFrame': 'Approximately 1 week after surgery', 'description': 'Bacterial growth was defined as plate growth of 1+ or greater. Drains were removed at variable times across patients, per clinical indication. When clinically indicated, some patients did have their drains removed at the one week visit, in which case they only had one bulb fluid culture.'}, {'measure': 'Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week', 'timeFrame': 'Approximately 1 week after surgery'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Drain Tubing Colonization at Removal', 'timeFrame': 'Approximately two weeks after surgery', 'description': 'Drain tubing colonization was defined as greater than 50 colony forming units. Drains were removed at variable timepoints based on the clinical situation.'}, {'measure': 'Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Removal', 'timeFrame': 'Approximately 2 weeks after surgery', 'description': 'Bacterial growth was defined as plate growth of 1+ or greater. Drains were removed a variable times across patients, per clinical indication. A second bulb culture was obtained later than 1 week ONLY in those drains that were not removed at 1 week.'}, {'measure': 'Number of Subjects With Surgical Site Infection Within 30 Days', 'timeFrame': 'Approximately 30 days after surgery'}, {'measure': 'Number of Subjects With Surgical Site Infection Within 1 Year', 'timeFrame': 'Approximately one year after surgery'}, {'measure': 'Per Drain Analysis: Drain Tubing Colonization at Removal', 'timeFrame': 'Approximately one month after surgery'}, {'measure': 'Per Drain Analysis: Drain Bulb Fluid Colonization at Removal', 'timeFrame': 'Approximately one month after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bilateral breast mastectomy', 'Immediate tissue expanders reconstruction'], 'conditions': ['Nonmalignant Breast Conditions', 'Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '23518704', 'type': 'DERIVED', 'citation': 'Degnim AC, Scow JS, Hoskin TL, Miller JP, Loprinzi M, Boughey JC, Jakub JW, Throckmorton A, Patel R, Baddour LM. Randomized controlled trial to reduce bacterial colonization of surgical drains after breast and axillary operations. Ann Surg. 2013 Aug;258(2):240-7. doi: 10.1097/SLA.0b013e31828c0b85.'}]}, 'descriptionModule': {'briefSummary': 'Surgical site infection (SSI) after breast and axillary surgery occurs more often than for other clean surgical procedures. Infection in the setting of a tissue expander can be devastating and can lead to early implant loss and failed reconstruction. Surgical drains have been noted as a potential source for surgical site infections. Hypothesis: Bacteria present in surgical drains after tissue expander reconstruction may be decreased by simple and inexpensive local antiseptic interventions.', 'detailedDescription': "Surgical Site infection after breast surgical procedures occurs more frequently than for other clean surgical procedures. Considering the large numbers of patients who undergo breast-related procedures per year and the increasing use of immediate breast reconstruction with placement of tissue expanders or immediate implant reconstruction, a surgical site infection involving the implant can result in its removal and a failed reconstruction.\n\nThe primary aim of the study is to determine if chlorhexidine disk application and irrigation of the drainage bulb with dilute Dakin's solution (buffered sodium hypochlorite solution)after tissue expander breast reconstruction or immediate implant reconstruction, effectively decreases rates of bacterial colonization in drain fluid compared to standard care.\n\nMethods:\n\nPatients undergoing bilateral immediate reconstruction with tissue expander placement will have one surgical site treated with standard drain care and the other treated with a drain antisepsis regimen. Drain antisepsis intervention will consist of two measures: 1) placement of a chlorhexidine sponge dressing at the drain exit site, and 2) twice daily irrigation of the drainage bulb with dilute Dakin's solution (buffered hypochlorite).\n\nAll patients will undergo semiquantitative cultures of the drain bulb at one week postoperatively. This culture will be repeated at the time of drain removal, with simultaneous cultures of the fluid in the bulb as well as an internal segment of each removed drainage tube. All patients will be evaluated for clinical signs of infection and for any adverse reactions to the drain antisepsis at the follow-up visits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Females or males age 18-90 able to give informed consent\n* Undergoing bilateral mastectomy with immediate expander reconstruction or immediate implant reconstruction\n* May have either malignant or benign breast condition\n\nExclusion Criteria:\n\n* Antibiotic use in the fourteen days prior to surgical date\n* Undergoing unilateral tissue expander reconstruction\n* Documented allergy to chlorhexidine gluconate\n* Prior radiation therapy to the breast or chest wall (ie for breast conservation or mantle radiation for Hodgkin's disease)\n* Documented allergy to all three of the following antibiotics: cephalosporin, trimethoprim/sulfamethoxazole, and levofloxacin\n* Pregnant women\n* Vulnerable subjects - prisoners, institutionalized individuals\n* Non-English speaking patients without adequate interpreter assistance"}, 'identificationModule': {'nctId': 'NCT01286168', 'briefTitle': 'Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction', 'orgStudyIdInfo': {'id': '10-008061'}, 'secondaryIdInfos': [{'id': 'UL1TR000135', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR000135', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antisepsis Side', 'description': "A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days. The drainage bulb will be irrigated with 10ml of 0.125% sodium hypochlorite (Dakin's solution) twice a day.", 'interventionNames': ["Device: Sodium hypochlorite (Dakin's Solution)", 'Device: Chlorhexidine gluconate disk', 'Device: Occlusive Adhesive Dressing']}, {'type': 'OTHER', 'label': 'Control Side', 'description': 'Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care.', 'interventionNames': ['Procedure: Control']}], 'interventions': [{'name': "Sodium hypochlorite (Dakin's Solution)", 'type': 'DEVICE', 'otherNames': ["Dakin's solution", 'Wound cleanser'], 'description': "10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day", 'armGroupLabels': ['Antisepsis Side']}, {'name': 'Chlorhexidine gluconate disk', 'type': 'DEVICE', 'otherNames': ['BioPatch Protective Disk with CHG'], 'description': 'Apply one chlorhexidine disk to the intervention drain site(s) and change every three days', 'armGroupLabels': ['Antisepsis Side']}, {'name': 'Control', 'type': 'PROCEDURE', 'description': 'Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care.', 'armGroupLabels': ['Control Side']}, {'name': 'Occlusive Adhesive Dressing', 'type': 'DEVICE', 'otherNames': ['Tegaderm CHG Dressing'], 'description': 'A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days.', 'armGroupLabels': ['Antisepsis Side']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94107', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '55904', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Amy C Degnim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic, Rochester, MN'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': 'Ethicon, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Amy C. Degnim', 'investigatorAffiliation': 'Mayo Clinic'}}}}