NCT01912651 The Role of Antibiotics in Full Thickness Skin Graft Survival for Facial Reconstructive Surgery
| NCT ID | NCT01912651 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Michigan |
| Condition | Facial Defect |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2013-07 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 300 participants in total. It began in 2013-07 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. Our 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.
Eligibility Criteria
Inclusion Criteria: * all adult patients with a nasal or facial skin/soft tissue defect requiring reconstruction limited to or including a full-thickness skin graft Exclusion Criteria: * 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.
Contact & Investigator
Jeffrey Y Moyer, MD
PRINCIPAL INVESTIGATOR
University of Michigan Otolaryngology
Frequently Asked Questions
Who can join the NCT01912651 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Facial Defect. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01912651 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT01912651 currently recruiting?
Yes, NCT01912651 is actively recruiting participants. Contact the research team at jmoyer@med.umich.edu for enrollment information.
Where is the NCT01912651 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT01912651 clinical trial?
NCT01912651 is sponsored by University of Michigan. The principal investigator is Jeffrey Y Moyer, MD at University of Michigan Otolaryngology. The trial plans to enroll 300 participants.