Abstract
BACKGROUND: Follicular unit extraction (FUE) hair transplantation subjects are excellent candidates to assess wound dressings. The wound surface area is large and adequately delineated to allow randomization, while in-patient split scalp designs allow patients to serve as their own controls. OBJECTIVES: This randomized, single-blinded, split-scalp comparison trial compares a novel, film-forming silicone gel-Stratamed (SM; Stratpharma AG, Basel, Switzerland)-to Bacitracin (Bac; McKesson Medical-Surgical Inc., Richmond, VA) in subjects undergoing FUE. METHODS: Twenty subjects were randomized to receive SM and Bac on alternating sides of the scalp. Primary outcome measures included blinded clinician assessments of edema, erythema, crusting, healing response and outcome preference. Secondary measures included subject-reported assessments of pain and pruritis as well as FaceQ scores taken at post-FUE days two through six. RESULTS: Twenty subjects were enrolled. Nineteen completed the trial. All subjects were non-smokers, and none had medical comorbidities expected to impact wound healing. An average of 1778 follicles per subject were harvested. No adverse events were reported, and all subjects healed by day 7. Healing response and outcome preference were significantly higher at day 1 in the SM group and by day 7, both groups were similar. There were no significant differences between groups for edema, erythema, or crusting. There were no significant differences between groups for subject-reported outcomes of pain, pruritis, or FACE-Q scores. When asked which product they preferred using, 44% of subjects preferred using SM versus 22% who preferred Bac. CONCLUSIONS: The SM wound dressing was well-tolerated in patients undergoing FUE. SM may speed the healing response in the early phase of wound healing.