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 (Stratpharma AG, Basel, Switzerland) -- to Bacitracin (McKesson Medical-Surgical Inc., Richmond, VA) in subjects undergoing FUE.
Methods
Twenty subjects were randomized to receive Stratamed and Bacitracin 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 Stratamed 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 Stratamed versus 22% who preferred Bacitracin.
Conclusions
The Stratamed wound dressing was well-tolerated in patients undergoing FUE. Stratamed may speed the healing response in the early phase of wound healing.
Comparison of a Novel Silicone Gel Wound Dressing versus Bacitracin after Follicular Unit Extraction Hair Transplantation
