Amniotic Membrane for Donor Site Healing

NCT02947737 | Completed

• 1 other identifier: IRB00088758
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Burns

Keywords

Skin graft

Outcome Measures

Primary Outcomes (4)

• Change in postoperative pain

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

  Postoperative days 1, 2 and 5

• Change in re-epithelialization

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

  Postoperative days 2 and 5

• Comparison of scarring between donor sites

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

  Postoperative day 5

• Comparison of hypopigmentation between donor sites

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

  Postoperative day 5

Study Arms (2)

Amniotic membrane dressing

EXPERIMENTAL

One donor site per study participant will be covered with an amniotic membrane dressing.

Other: Amniotic membrane dressing

Gentamicin and xeroform dressing

ACTIVE COMPARATOR

One donor site per study participant will be covered with a gentamicin and xeroform dressing.

Other: Gentamicin and xeroform dressing

Interventions

Amniotic membrane dressing OTHER

We will place an amniotic membrane dressing on the donor site

Amniotic membrane dressing

Gentamicin and xeroform dressing OTHER

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

Gentamicin and xeroform dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• less than 18 years of age

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Biological Dressings; Gentamicins

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Rachael Williams, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: October 28, 2016
• Study Start: February 1, 2017
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: May 21, 2018

Record last verified: 2018-05

Locations

US (1)