We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02947737
Previous Study | Return to List | Next Study

Amniotic Membrane for Donor Site Healing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02947737
Recruitment Status : Completed
First Posted : October 28, 2016
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Rachael Williams, Emory University

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.

Condition or disease Intervention/treatment Phase
Burns Other: Amniotic membrane dressing Other: Gentamicin and xeroform dressing Not Applicable

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Investigating the Effects of Amniotic Membrane on Donor Site Healing and Postoperative Pain
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Organ Donation

Arm Intervention/treatment
Experimental: Amniotic membrane dressing
One donor site per study participant will be covered with an amniotic membrane dressing.
Other: Amniotic membrane dressing
We will place an amniotic membrane dressing on the donor site

Active Comparator: Gentamicin and xeroform dressing
One donor site per study participant will be covered with a gentamicin and xeroform dressing.
Other: Gentamicin and xeroform dressing
We will place xeroform, gentamicin and telfa on the donor site




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • less than 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947737


Locations
Layout table for location information
United States, Georgia
Grady Health System
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Investigators
Layout table for investigator information
Principal Investigator: Rachael Williams, MD Emory University
Layout table for additonal information
Responsible Party: Rachael Williams, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT02947737    
Other Study ID Numbers: IRB00088758
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rachael Williams, Emory University:
Skin graft
Additional relevant MeSH terms:
Layout table for MeSH terms
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action