Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-26 @ 4:47 PM
Study NCT ID:
NCT01912651
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2013-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Antibiotics in Full Thickness Skin Graft Survival for Facial Reconstructive Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002506', 'term': 'Cephalexin'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-15', 'studyFirstSubmitDate': '2013-07-29', 'studyFirstSubmitQcDate': '2013-07-29', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Graft failure rate', 'timeFrame': '1 year', 'description': 'The primary outcomes will be graft failure rate where failure is defined as any tissue loss extending beyond the epithelium.'}], 'secondaryOutcomes': [{'measure': 'Percentage surface area of graft failure', 'timeFrame': '1 year', 'description': 'The secondary outcomes include the percentage surface area of graft failure, the incidence of post-operative adjunctive procedures related to graft cosmesis and the incidence of revision surgery resulting from graft failure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['facial skin wound', 'facial wound', 'skin wound', 'facial defect', 'reconstructive skin graft'], 'conditions': ['Facial Defect']}, 'descriptionModule': {'briefSummary': 'Antibiotics are sometimes prescribed to patients who have had reconstructive surgery of wounds on their face using skin grafts. But, it is not yet known whether antibiotics improve the healing of skin grafts and reduce the risk of infections after surgery in these patients. It is known that antibiotics, like all medications, have side-effects although these are rare. This research study is designed to show us whether antibiotics improve wound healing or not, so that we may determine if we should continue using antibiotics even if they have side-effects in some patients.\n\nOur hypothesis is that patients treated with post-operative, systemic antibiotics will demonstrate a statistically significant improvement in the survival of their facial full thickness skin grafts compared to patients who are not treated with systemic antibiotics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all adult patients with a nasal or facial skin/soft tissue defect requiring reconstruction limited to or including a full-thickness skin graft\n\nExclusion Criteria:\n\n* current or recent (within one week of surgery) systemic antibiotic use, intolerance to both clindamycin and cephalexin, discovery of a persistent cutaneous malignancy at the site of the defect following the reconstructive procedure and previous reconstruction at the site of the skin/soft-tissue defect.'}, 'identificationModule': {'nctId': 'NCT01912651', 'briefTitle': 'The Role of Antibiotics in Full Thickness Skin Graft Survival for Facial Reconstructive Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'The Role of Antibiotics in Full Thickness Skin Graft Survival for Facial Reconstructive Surgery', 'orgStudyIdInfo': {'id': '00046677'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No antibiotic treatment', 'description': 'Withholding post-operative antibiotics following reconstructive surgery necessitating skin grafting for defects of the face or nose.'}, {'type': 'EXPERIMENTAL', 'label': 'Antibiotics', 'description': 'All patients will receive peri-operative antibiotics per standard practice. This consists of a single dose of cefazolin or, in penicillin allergic patients, clindamycin administered at the time of anesthesia administration prior to the surgical incision. In the cohort randomized to receive post-operative antibiotics, the first choice intervention will be oral cephalexin (500 mg, three times daily or four times daily, for one week). In patients who are penicillin or cephalosporin allergic, we will prescribe clindamycin (300 mg, three times daily or four times daily, for one week).', 'interventionNames': ['Drug: cephalexin']}], 'interventions': [{'name': 'cephalexin', 'type': 'DRUG', 'description': 'This consists of a single dose of cefazolin or, in penicillin allergic patients, clindamycin administered at the time of anesthesia administration prior to the surgical incision. In the cohort randomized to receive post-operative antibiotics, the first choice intervention will be oral cephalexin (500 mg, three times daily or four times daily, for one week). In patients who are penicillin or cephalosporin allergic, we will prescribe clindamycin (300 mg, three times daily or four times daily, for one week). Patients will be followed up within 2 to 6 weeks of surgery and outcome measures assessed. Patients will, again, be seen at 6 months and 1 year post-operatively for outcome assessment.', 'armGroupLabels': ['Antibiotics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Moyer, MD', 'role': 'CONTACT', 'email': 'jmoyer@med.umich.edu', 'phone': '734-936-8051'}, {'name': 'Jeffrey Moyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'Jeffrey S Moyer, MD', 'role': 'CONTACT', 'email': 'jmoyer@med.umich.edu', 'phone': '734-936-8051'}], 'overallOfficials': [{'name': 'Jeffrey Y Moyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan Otolaryngology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Otolaryngology-Head and Neck Surgery, Medical School', 'investigatorFullName': 'Jeffrey Moyer', 'investigatorAffiliation': 'University of Michigan'}}}}