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

Not Applicable

Completed

• Conditions: Wounds and Injuries
• Interventions: Device: Treatment - Stratamed

• Registration Number: NCT03843996
• Lead Sponsor: Stratpharma AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-03
• Primary Completion: 2018-12-14
• Study Completion: 2019-01-08
• Status Verified: 2019-02
• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-13
• Last Update Submitted: 2019-02-13
• Study First Posted: 2019-02-18
• Last Update Posted: 2019-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment left	Treatment - Stratamed	A randomized side of the scalp will be treated with Stratamed®, the other side with standard clinical practice.
Treatment right	Treatment - Stratamed	A randomized side of the scalp will be treated with Stratamed®, the other side with standard clinical practice.

Primary Outcome Measures

Name	Time	Method
Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1)	duration of the studybe evaluated and rated on days 1 (+1) and 7 (±1) post procedure for both the investigational and standard treatment products	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%)

Trial Locations

Locations (1)

New Jersey Plastic Surgery, Montclair, NJ USA; 🇺🇸 Montclair, New Jersey, United States