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NCT Number: NCT02947737

Amniotic Membrane for Donor Site Healing

The purpose of this study is to compare the effectiveness of applying amniotic membrane dressings compared to gentamicin and xeroform dressings to donor sites for skin grafts. This study will enroll ten participants who undergoing a split thickness skin graft procedure with two or more donor sites. The amniotic membrane will be applied to one donor site and a dressing of xeroform and gentamicin will be applied to another other donor site. Each participant will receive both types of dressing and will serve as their own control. Postoperative follow up will follow standard of care, regardless of the dressing type. Dressings will be removed on postoperative day 4 and participants will return to be re-examined one week after being discharged from the hospital.

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Key information

Conditions

Burns Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grady Health System

Atlanta, Georgia, 30303, United States

About this study

The use of amniotic membrane in the treatment of wounds has been employed for almost 100 years, with reports of it being used in skin grafting for burns and ulcers in 1913. This study will investigate the use of amniotic membrane as a donor site dressing (the area where skin is removed to be transplanted to the recipient site). Donor sites are often a significant cause of postoperative pain for patients who have undergone skin grafts. Furthermore, donor sites that fail to re-epithelialize or scar may require additional excision and skin grafting on the donor site itself. There is a paucity of literature in the United States regarding the use of amniotic membrane as a donor site dressing, however, studies from other countries have demonstrated an increase in patient comfort and a faster time to re-epithelialization. Inherent to amniotic membrane that makes it an ideal dressing include the presence of extracellular matrix components create integrity, epithelial cells participate in the healing process, and defensins confer antibacterial properties. MiMedx produces AmnioFix® which is a dehydrated preserved amniotic membrane that will be used in the dressing of our donor sites in contrast to gentamicin and xeroform based dressings. This study will see if patients have improved cosmetic outcomes, less postoperative pain and a faster time to re-epithelialization at the donor site treated with amniotic membrane compared to the standard of care.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • undergoing a split thickness skin graft procedure with two or more donor sites

Exclusion criteria

  • less than 18 years of age

Treatment and study plan

Amniotic membrane dressing

Other

We will place an amniotic membrane dressing on the donor site

Gentamicin and xeroform dressing

Other

We will place xeroform, gentamicin and telfa on the donor site

Primary outcomes

  1. Change in postoperative pain

    Time frame: Postoperative days 1, 2 and 5

    Participants will report their pain level for each donor site as a numeric score from 1 to 10.

  2. Change in re-epithelialization

    Time frame: Postoperative days 2 and 5

    The percent of re-epithelialization for each donor site will be evaluated by burn unit surgeons on postoperative days 2 and 5.

  3. Comparison of scarring between donor sites

    Time frame: Postoperative day 5

    Scarring on postoperative day 5 will be evaluated by burn unit surgeons

  4. Comparison of hypopigmentation between donor sites

    Time frame: Postoperative day 5

    Hypopigmentation on postoperative day 5 will be evaluated by burn unit surgeons.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Investigating the Effects of Amniotic Membrane on Donor Site Healing and Postoperative Pain

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 28, 2016
Registry last updated
May 21, 2018

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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