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The Role of Antibiotics in Full Thickness Skin Graft Survival for Facial Reconstructive Surgery

Information source: University of Michigan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Facial Defect

Intervention: cephalexin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Michigan

Official(s) and/or principal investigator(s):
Jeffrey Y Moyer, MD, Principal Investigator, Affiliation: University of Michigan Otolaryngology

Overall contact:
Jeffrey S Moyer, MD, Phone: 734-936-8051, Email: jmoyer@med.umich.edu

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.

Clinical Details

Official title: The Role of Antibiotics in Full Thickness Skin Graft Survival for Facial Reconstructive Surgery

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Graft failure rate

Secondary outcome: Percentage surface area of graft failure

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Jeffrey S Moyer, MD, Phone: 734-936-8051, Email: jmoyer@med.umich.edu

University of Michigan, Ann Arbor, Michigan 48109, United States; Recruiting
Jeffrey Moyer, MD, Phone: 734-936-8051, Email: jmoyer@med.umich.edu
Jeffrey Moyer, MD, Principal Investigator
Additional Information

Starting date: July 2013
Last updated: August 11, 2015

Page last updated: August 23, 2015

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