Healing of Donor SitePhase 4NCT01252836
Study Evaluating AWBAT-D Versus the Standard of Care of Split-thickness Skin Graft Donor Sites
A Phase 4 study testing AWBAT-D in people with Healing of Donor Site and Pain Level, run by Georgetown University at 1 site in United States.
Trial summary
Use of AWBAT-D on split thickness skin graft sites will reduce healing time and pain level. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healing of Donor Site, Pain Level
- What is being tested?
- AWBAT-D
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Apr 2015
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is 18 years of age or older
- Subjects requiring a split-thickness skin graft with a wound size between 5 and 50cm2 and a depth between 12-18um.
- Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study.
Who cannot join
- Subjects < 18 years of age
- Subjects with an allergy to porcine products.
- Subjects undergoing STSG with a wound size less than 5 cm2 or greater than 50cm2.
- Subjects undergoing STSG with a wound depth of less than 12um or greater than 18um.
- Subjects undergoing repeat skin graft harvesting at the same donor site.
- Has active malignant disease of any kind. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry.
- Subjects participating in any other trials involving the split-thickness skin graft donor site.
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Hospital Center for Wound Healing
Washington D.C., District of Columbia, 20007
About this study
Official title: Randomized, Prospective, Pilot Study Evaluating a Temporary Skin Substitute (AWBAT-D) Versus the Standard of Care in the Postoperative Treatment of Split-thickness Skin Graft Donor Sites
Use of AWBAT-D on split thickness skin graft sites will reduce healing time and pain level.
Read the detailed description
The study is designed as a randomized-controlled trial to examine split thickness skin graft donor wound site healing using AWBAT-D compared to current standard of care: Tegaderm. This will involve randomizing subjects to treatment with the AWBAT-D dressing or Tegaderm and monitoring outcomes. The AWBAT-D device has collagen and we hypothesize that the wounds treated with it will heal faster and with a decreased pain level. The purpose of this study is to evaluate if there are differences in outcomes between AWBAT-D and Tegaderm in healing split thickness skin graft donor sites.
- Conditions
- Healing of Donor Site, Pain Level
- Being tested
- AWBAT-D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AWBAT-DDevice
Application of AWBAT-D bioengineered device
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Treatment with Tegaderm Receives: Device: AWBAT-D |
| AWBAT-D | Experimental | Application of AWBAT-D on donor site. Receives: Device: AWBAT-D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for donor site to heal with AWBAT-D
As compared to current standard of care, Tegaderm.
Measured: 6 weeks
Secondary outcomes (1)
Pain at donor site
Pain at donor site is less than that of standard of care treatment, Tegaderm.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: P.I decided to prematurely end this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healing of Donor SiteStudies of the same condition, open and under way.
- More trials run by Georgetown 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Attinger, M.D., Georgetown University
- Investigators
- Christopher A Attinger, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252836
- Sponsor's protocol ID
- 2010-160
- Status last verified
- Dec 2016
- First submitted
- 1 Dec 2010
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data was not collected for use in future research and will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective, Pilot Study Evaluating a Temporary Skin Substitute (AWBAT-D) Versus the Standard of Care in the Postoperative Treatment of Split-thickness Skin Graft Donor Sites
- ClinicalTrials.gov ID
- NCT01252836
- Acronym / sponsor ID
- 2010-160
- Conditions
- Healing of Donor Site, Pain Level
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: P.I decided to prematurely end this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 3 Dec 2010 (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.
Use of AWBAT-D on split thickness skin graft sites will reduce healing time and pain level.
Detailed description
The study is designed as a randomized-controlled trial to examine split thickness skin graft donor wound site healing using AWBAT-D compared to current standard of care: Tegaderm. This will involve randomizing subjects to treatment with the AWBAT-D dressing or Tegaderm and monitoring outcomes. The AWBAT-D device has collagen and we hypothesize that the wounds treated with it will heal faster and with a decreased pain level. The purpose of this study is to evaluate if there are differences in outcomes between AWBAT-D and Tegaderm in healing split thickness skin graft donor sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Device: AWBAT-DTreatment with Tegaderm |
| AWBAT-D | Experimental | Device: AWBAT-DApplication of AWBAT-D on donor site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is 18 years of age or older
- Subjects requiring a split-thickness skin graft with a wound size between 5 and 50cm2 and a depth between 12-18um.
- Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study.
Key exclusion criteria (7 listed)
- Subjects < 18 years of age
- Subjects with an allergy to porcine products.
- Subjects undergoing STSG with a wound size less than 5 cm2 or greater than 50cm2.
- Subjects undergoing STSG with a wound depth of less than 12um or greater than 18um.
- Subjects undergoing repeat skin graft harvesting at the same donor site.
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 |
|---|---|---|
| AWBAT-DApplication of AWBAT-D bioengineered device | Device | AWBAT-D, Control |
Primary outcome
Time for donor site to heal with AWBAT-D
Time frame: 6 weeks
As compared to current standard of care, Tegaderm.
1 secondary outcome
Pain at donor site
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
- Individual participant dataSharing planned: No. Data was not collected for use in future research and will not be shared.
Related trials for Healing of Donor Site
Not yet recruiting
Autologous Skin Cell Suspension (RECELL®) for Accelerated Healing of Split-Thickness Skin Graft Donor Sites: A Randomized, Intra-Patient (Split-Site) Controlled Trial
Skin Graft Donor Site, Wound Healing
Recruiting
Negative Pressure Wound Therapy in Healing Abdominal Incision in Obese Patients Undergoing Breast Reconstruction Surgery
Body Mass Index Greater Than or Equal to 30, Malignant Breast Neoplasm
Not yet recruitingPhase 4
Impact of Dysport on PMFF Donor Scar
Skin Cancer Excision Site, Basal Cell Carcinoma
Active, not recruiting
Effect of Frankincense Versus Palatal Stent on Palatal Donor Site Healing
Palatal Donor Site Wound Healing
Recruiting
Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques
Mucosal Erosion, Gingival Recession
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.
Christopher A Attinger, MD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AWBAT-D in people with Healing of Donor Site and Pain Level, run by Georgetown 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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 15 Dec 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Time for donor site to heal with AWBAT-D (time frame: 6 weeks). 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 15 Dec 2016.