- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00392301
Split-Thickness Skin Graft Donor Site Wound Healing Study
February 20, 2018 updated by: Annette Wysocki, PhD, RN, University of Mississippi Medical Center
The purpose of this research study is to discover whether instruments widely used in skin research can be used to measure wound healing in split thickness skin graft donor sites and whether these instruments can detect differences in healing when two different dressing products are used.
Study Overview
Status
Withdrawn
Conditions
Detailed Description
Currently there is no standard treatment to promote wound healing for split thickness skin graft donor sites and healing is determined based on clinical observation of the graft donor site and clinical judgement.
Here we propose to use two instruments commonly used in skin research to measure wound healing.
This study will validate the use of these two instruments, one that measures transepidermal water loss and the other that measures skin pigmentation to determine healing.
To further validate the use of these instruments we will determine if these instruments can detect differences between two different wound dressing products that have been previously reported to heal skin graft donor sites at different rates.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects with split thickness skin graft donor sites
Description
Inclusion Criteria:
- Participants 18 years of age and over who have a split-thickness skin graft donor site.
Exclusion Criteria:
- Individuals under 18 years of age.
- Individuals who do not have a split thickness skin graft donor site.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Annette B. Wysocki, PhD, RN, University of Mississippi Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Disa JJ, Alizadeh K, Smith JW, Hu Q, Cordeiro PG. Evaluation of a combined calcium sodium alginate and bio-occlusive membrane dressing in the management of split-thickness skin graft donor sites. Ann Plast Surg. 2001 Apr;46(4):405-8. doi: 10.1097/00000637-200104000-00009.
- Feldman DL, Rogers A, Karpinski RH. A prospective trial comparing Biobrane, Duoderm and xeroform for skin graft donor sites. Surg Gynecol Obstet. 1991 Jul;173(1):1-5.
- Feldman DL. Which dressing for split-thickness skin graft donor sites? Ann Plast Surg. 1991 Sep;27(3):288-91. doi: 10.1097/00000637-199109000-00017.
- Kilinc H, Sensoz O, Ozdemir R, Unlu RE, Baran C. Which dressing for split-thickness skin graft donor sites? Ann Plast Surg. 2001 Apr;46(4):409-14. doi: 10.1097/00000637-200104000-00010.
- Malpass KG, Snelling CF, Tron V. Comparison of donor-site healing under Xeroform and Jelonet dressings: unexpected findings. Plast Reconstr Surg. 2003 Aug;112(2):430-9. doi: 10.1097/01.PRS.0000070408.33700.C7.
- Rakel BA, Bermel MA, Abbott LI, Baumler SK, Burger MR, Dawson CJ, Heinle JA, Ocheltree IM. Split-thickness skin graft donor site care: a quantitative synthesis of the research. Appl Nurs Res. 1998 Nov;11(4):174-82. doi: 10.1016/s0897-1897(98)80296-6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2009
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
October 23, 2006
First Submitted That Met QC Criteria
October 24, 2006
First Posted (Estimate)
October 25, 2006
Study Record Updates
Last Update Posted (Actual)
February 22, 2018
Last Update Submitted That Met QC Criteria
February 20, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 2006-0094
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Split-thickness Skin Graft Donor Sites
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Brigham and Women's HospitalMedline IndustriesCompletedSplit-thickness Skin Graft Donor Sites
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Lee's Pharmaceutical LimitedGuangzhou First People's Hospital; Ruijin HospitalCompletedSplit-thickness Skin Graft Donor Sites
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Brigham and Women's HospitalWithdrawnBurns | Split-thickness Skin Graft Donor Sites
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ConvaTec Inc.Bristol-Myers SquibbCompletedSplit-Thickness Donor Sites.United States
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ULURU Inc.CompletedPartial-thickness Skin Donor SitesUnited States
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Klinik BogenhausenCompletedReepithelialization of Skin Graft Donor SitesGermany
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Nantes University HospitalRecruitingWound Healing | Split Thickness Skin GraftFrance
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PT. Daewoong InfionEquilab InternationalCompletedSkin Graft Scar | Split-Thickness Skin Graft (STSG)Indonesia
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Birken AGCompletedAccelerating the Epithelialization of Split Thickness Skin GraftGermany
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Molnlycke Health Care ABCompletedAcute Wound | Donor Site | Split Skin GraftSweden