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OpenTrials
Completed

NCT Number: NCT03843996

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

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.

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Key information

Conditions

Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Jersey Plastic Surgery, Montclair, NJ USA

Montclair, New Jersey, 07042, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment - Stratamed

Device

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.

Other names: wound healing

Primary outcomes

  1. Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1)

    Time frame: 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%)

Sponsors and collaborators

Lead sponsor

Stratpharma AG

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Feb 18, 2019
Registry last updated
Feb 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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