Split-thickness Skin Graft Donor SitesNCT00392301
Split-Thickness Skin Graft Donor Site Wound Healing Study
An observational study of Split-thickness Skin Graft Donor Sites, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Split-thickness Skin Graft Donor Sites
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to 1 Jul 2012
- Phase
- Observational
- 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
Study population: Subjects with split thickness skin graft donor sites
Who may be able to join
- Participants 18 years of age and over who have a split-thickness skin graft donor site.
Who cannot join
- Individuals under 18 years of age.
- Individuals who do not have a split thickness skin graft donor site.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
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.
Read the 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.
- Conditions
- Split-thickness Skin Graft Donor Sites
- Keywords
- wound healing, skin, graft donor site, donor site, transepidermal water loss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2006 (estimated)
- Study startOct 2009 (estimated)
- Primary completion1 Jul 2012
- Study completion1 Jul 2012
Why it stopped: Not funded - and PI left for another position in 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Split-thickness Skin Graft Donor SitesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annette Wysocki, PhD, RN, University of Massachusetts, Amherst
- Investigators
- Annette B. Wysocki, PhD, RN, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392301
- Sponsor's protocol ID
- 2006-0094
- Status last verified
- Feb 2018
- First submitted
- 23 Oct 2006
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 11324883Feldman 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.
PubMed 1907769Feldman 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.
PubMed 1952757Kilinc 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.
PubMed 11324884Malpass 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.
PubMed 12900600Rakel 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.
PubMed 9852660
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Split-Thickness Skin Graft Donor Site Wound Healing Study
- ClinicalTrials.gov ID
- NCT00392301
- Acronym / sponsor ID
- 2006-0094
- Conditions
- Split-thickness Skin Graft Donor Sites
- Keywords
- wound healing, skin, graft donor site, donor site, transepidermal water loss
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not funded - and PI left for another position in 2012
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Oct 2009 (estimated)
- Primary completion
- 1 Jul 2012 (actual)
- Study completion
- 1 Jul 2012 (actual)
- First posted
- 25 Oct 2006 (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 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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with split thickness skin graft donor sites
Key inclusion criteria (1 listed)
- Participants 18 years of age and over who have a split-thickness skin graft donor site.
Key exclusion criteria (2 listed)
- Individuals under 18 years of age.
- Individuals who do not have a split thickness skin graft 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.
Primary outcome
Not reported in the source record.
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 22 Feb 2018.
- Background: PubMed 11324883Disa 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.
- Background: PubMed 1907769Feldman 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.
- Background: PubMed 1952757Feldman 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.
- Background: PubMed 11324884Kilinc 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.
- Background: PubMed 12900600Malpass 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.
- Background: PubMed 9852660Rakel 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.
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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.
Annette B. Wysocki, PhD, RN principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Split-thickness Skin Graft Donor Sites, run by University of Mississippi Medical Center 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 2 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 22 Feb 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00392301, which also lists 6 linked publications.
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 22 Feb 2018.