BurnsNCT02947737
Amniotic Membrane for Donor Site Healing
A study testing Amniotic membrane dressing and Gentamicin and xeroform dressing in people with Burns, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Amniotic membrane dressing and Gentamicin and xeroform dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 31 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing a split thickness skin graft procedure with two or more donor sites
Who cannot join
- less than 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effects of Amniotic Membrane on Donor Site Healing and Postoperative Pain
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.
Read the 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.
- Conditions
- Burns
- Being tested
- Amniotic membrane dressing, Gentamicin and xeroform dressing
- Keywords
- Skin graft
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic membrane dressingOther
We will place an amniotic membrane dressing on the donor site
Gentamicin and xeroform dressingOther
We will place xeroform, gentamicin and telfa on the donor site
| Study group | Role | What they receive |
|---|---|---|
| Amniotic membrane dressing | Experimental | One donor site per study participant will be covered with an amniotic membrane dressing. Receives: 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. Receives: Other: Gentamicin and xeroform dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postoperative pain
Participants will report their pain level for each donor site as a numeric score from 1 to 10.
Measured: 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.
Measured: Postoperative days 2 and 5
Comparison of scarring between donor sites
Scarring on postoperative day 5 will be evaluated by burn unit surgeons
Measured: Postoperative day 5
Comparison of hypopigmentation between donor sites
Hypopigmentation on postoperative day 5 will be evaluated by burn unit surgeons.
Measured: Postoperative day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study start1 Feb 2017
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachael Williams, Emory University
- Investigators
- Rachael Williams, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947737
- Sponsor's protocol ID
- IRB00088758
- Status last verified
- May 2018
- First submitted
- 26 Oct 2016
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Amniotic Membrane on Donor Site Healing and Postoperative Pain
- ClinicalTrials.gov ID
- NCT02947737
- Acronym / sponsor ID
- IRB00088758
- Conditions
- Burns
- Keywords
- Skin graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amniotic membrane dressing | Experimental | Other: Amniotic membrane dressingOne donor site per study participant will be covered with an amniotic membrane dressing. |
| Gentamicin and xeroform dressing | Active comparator | Other: Gentamicin and xeroform dressingOne donor site per study participant will be covered with a gentamicin and xeroform dressing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing a split thickness skin graft procedure with two or more donor sites
Key exclusion criteria (1 listed)
- less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amniotic membrane dressingWe will place an amniotic membrane dressing on the donor site | Other | Amniotic membrane dressing |
| Gentamicin and xeroform dressingWe will place xeroform, gentamicin and telfa on the donor site | Other | Gentamicin and xeroform dressing |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachael Williams, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amniotic membrane dressing and Gentamicin and xeroform dressing in people with Burns, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postoperative pain (time frame: Postoperative days 1, 2 and 5). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018.