Amniotic Membrane for Donor Site Healing
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|ClinicalTrials.gov Identifier: NCT02947737|
Recruitment Status : Completed
First Posted : October 28, 2016
Last Update Posted : May 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Burns||Other: Amniotic membrane dressing Other: Gentamicin and xeroform dressing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|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|
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
- 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.
- 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.
- Comparison of scarring between donor sites [ Time Frame: Postoperative day 5 ]Scarring on postoperative day 5 will be evaluated by burn unit surgeons
- Comparison of hypopigmentation between donor sites [ Time Frame: Postoperative day 5 ]Hypopigmentation on postoperative day 5 will be evaluated by burn unit surgeons.
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
|United States, Georgia|
|Grady Health System|
|Atlanta, Georgia, United States, 30303|
|Principal Investigator:||Rachael Williams, MD||Emory University|