Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-03-06 @ 2:31 PM
Study NCT ID:
NCT02253069
Status:
COMPLETED
Last Update Posted:
2015-12-09
First Post:
2014-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PHMB-based Antiseptic Use in Full-thickness Surgical Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-08', 'studyFirstSubmitDate': '2014-09-24', 'studyFirstSubmitQcDate': '2014-09-30', 'lastUpdatePostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measuring colony forming units in swabs collected from wounds pre-,intra- and postoperatively (7 days after surgery1). Change in bacterial load will be attributed to the effect of applying an antiseptic solution to wound dressings.', 'timeFrame': '7 days', 'description': 'Wounds will be swabbed at end of surgery and then 7 days after surgery. Number and type of bacteria present will be analysed. Our hypothesis is that applying the antiseptic solution to the tie-over dressings will show a suppressed growth of bacteria when measured 7 days after surgery.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Surgical Site Infections']}, 'referencesModule': {'references': [{'pmid': '21615603', 'type': 'BACKGROUND', 'citation': 'Saleh K, Sonesson A, Persson B, Riesbeck K, Schmidtchen A. A descriptive study of bacterial load of full-thickness surgical wounds in dermatologic surgery. Dermatol Surg. 2011 Jul;37(7):1014-22. doi: 10.1111/j.1524-4725.2011.02040.x. Epub 2011 May 25.'}]}, 'descriptionModule': {'briefSummary': 'To study the effect of applying a PHMB-based antiseptic solution to tie-over dressings in full-thickness surgical wounds in dermatologic surgery in order to minimise the development of surgical site infections. The bacterial dynamics in wounds pre-,intra-, and postoperatively will be examined in order to understand the pathogenesis of surgical site infections better.', 'detailedDescription': "40 patients with suspected skin cancer in the face planned for full-thickness surgery will be randomised into two groups: One will receive a traditional tie-over dressing saturated with NaCl and the other group will receive a tie-over dressing saturated with a PHMB-based antiseptic. A quantitative and qualitative bacterial analysis of wounds by using a modified Levine's swabbing technique will be carried out pre-,intra-,and postoperatively. The effect of nasal colonisation with S.aureus on the development of surgical site infections will be investigated. All wounds will be followed a week after surgery to assess development of infections."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients planned for full-thickness skin grafting in the face\n\nExclusion Criteria:\n\n* Patients with no diabetes\n* Patients with no current/previous/recent antibiotic therapy'}, 'identificationModule': {'nctId': 'NCT02253069', 'briefTitle': 'PHMB-based Antiseptic Use in Full-thickness Surgical Wounds', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'A Study of Polyhexanide-based Antiseptic in Full-thickness Surgical Wounds in Dermatologic Surgery', 'orgStudyIdInfo': {'id': 'Regionskane'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PHMB-based antiseptic', 'description': 'Applying Prontosan antiseptic solution to tie-over dressings', 'interventionNames': ['Device: Applying Prontosan antiseptic solution to tie-over dressings']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Applying water to tie-over dressings', 'interventionNames': ['Device: Applying Placebo to tie-over dressings']}], 'interventions': [{'name': 'Applying Prontosan antiseptic solution to tie-over dressings', 'type': 'DEVICE', 'description': 'Applying a PHMB-based antiseptic to tie-over dressings', 'armGroupLabels': ['PHMB-based antiseptic']}, {'name': 'Applying Placebo to tie-over dressings', 'type': 'DEVICE', 'description': 'Placebo control', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22185', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Department of dermatology, Skåne university hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Karim Saleh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology, Skåne University Hospital, Lund'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vinnova', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Karim Saleh', 'investigatorAffiliation': 'Region Skane'}}}}