Comparison of a Novel Wound Dressing Stratamed Versus Current Clinical Practice After Follicular Unit Extraction Hair Transplantation

Study Overview
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Brief Summary
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Follicular donor sites on the scalp for hair transplantation will be treated with studied products post harvest. A randomized side of the scalp will be treated with Stratamed, the other side with standard clinical practice. Subjects will be assessed live immediately post treatment and in 2 sessions during the healing phase post harvest. Subjects will also complete subject reported outcome questionnaires at home between study visits.

Official Title
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Comparison of a Novel Wound Dressing Stratamed Versus Current Clinical Practice After Follicular Unit Extraction Hair Transplantation

Conditions
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Wounds and Injuries

Intervention / Treatment
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* Device: Treatment - Stratamed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years old Able to provide informed consent Planning to undergo follicular unit extraction hair restoration Exclusion Criteria: Significant medical or surgical conditions Unable to give informed consent Patient unable to apply topical device Allergy or intolerance to ingredients or excipients of the formulation of studied products Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This Phase IV, post-marketing, single center study will be a single-blind, within subject split scalp efficacy comparison of Stratamed® and standard clinical practice, Bacitracin, post FUE. Twenty subjects desiring to undergo FUE for hair restoration will apply Stratamed® on one half of the donor area on the back of the scalp and Bacitracin on the other side at least twice a day for a week post procedure. The side of the scalp receiving each product will be randomized, and the evaluating physician will be blinded. Subjects will be evaluated, photographed, and will fill out subject reported questionnaires live at days 1 (+1) and 7 (±1) post procedure. Subjects will also fill out the subject reported questionnaires at home in between live study visits (days 2, 3, 4, 5, and 6).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment left<br>A randomized side of the scalp will be treated with Stratamed®, the other side with standard clinical practice. | Device: Treatment - Stratamed<br>* To determine if Stratamed is more effective than standard of care therapy in limiting severity and duration of signs and symptoms of acute inflammation post follicular harvesting procedure.<br>* Other names: wound healing;|
| Experimental: Treatment right<br>A randomized side of the scalp will be treated with Stratamed®, the other side with standard clinical practice. | Device: Treatment - Stratamed<br>* To determine if Stratamed is more effective than standard of care therapy in limiting severity and duration of signs and symptoms of acute inflammation post follicular harvesting procedure.<br>* Other names: wound healing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1) | Stratamed will improve the healing response vs. current standard of care therapy. Healing Response (4 point ordinal scale) LEFT SIDE Not healed at all (0%) Mildly healed (33%) Moderately healed (66%) Completely healed (100%) RIGHT SIDE Not healed at all (0%) Mild healing (33%) Moderately healed (66%) Completely healed (100%) | duration of the studybe evaluated and rated on days 1 (+1) and 7 (±1) post procedure for both the investigational and standard treatment products | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stratamed, wound healing, follicular unit extraction hair transplantation