Skin Graft DisorderNCT01974583
Wound-healing Improvement by Resurfacing Split-Thickness Skin Donor Sites With Thin Split-thickness Grafting
An observational study of Skin Graft Disorder and Disorder of Skin Donor Site, run by Tang-Du Hospital.
Trial summary
Split-thickness skin grafting remains fundamental treatment of patients with deep burns and other traumatic injuries. However, the split-thickness skin graft (STSG) donor site dressing has been controversial until now. Read more about this study
- Who is it for?
- Ages 5 to 56 years
- Conditions the study is for
- Skin Graft Disorder, Disorder of Skin Donor Site, Wound Healing Disturbance of
- What is being tested?
- regrafted with thin split-thickness skin graft, covered with the occlusive hydrocellular dressing and covered with paraffin gauze
- Type of treatment
- Surgery or procedure
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Mar 2013
- How long will I take part?
- 1 Year
- 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 5 to 56 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study cohort included 192 participants, who were randomly selected from patients who continuously received an STSG from January 2002 to December 2010 in Department of Burn and Plastic Surgery, Tangdu Hospital, Fourth Military Medical University.
Who may be able to join
- patients who continuously received an STSG from January 2002 to December 2010 in Department of Burn and Plastic Surgery, Tangdu Hospital, Fourth Military Medical University
Who cannot join
- The patients who were significant psychiatric, hypersensitive to silver, and not be followed up were excluded
About this study
Split-thickness skin grafting remains fundamental treatment of patients with deep burns and other traumatic injuries. However, the split-thickness skin graft (STSG) donor site dressing has been controversial until now. Our study here aimed to assess patient comfort and wound-healing efficacy with the application of thin split-thickness grafting on STSG donor sites.
Read the detailed description
Background：Split-thickness skin grafting remains fundamental treatment of patients with deep burns and other traumatic injuries. However, the split-thickness skin graft (STSG) donor site dressing has been controversial until now. Our study here aimed to assess patient comfort and wound-healing efficacy with the application of thin split-thickness grafting on STSG donor sites.
Methods: 192 consecutive patients undergoing split-thickness skin grafting were included in the study and the participants were randomly divided into three groups: Group A was regrafted with thin STSG, while, Group B and Group C were covered with the occlusive hydrocellular dressing and paraffin gauze, respectively. The three groups were compared regarding to the time of epithelialization, pain sensed by the patients and the scar formation.
- Being tested
- regrafted with thin split-thickness skin graft, covered with the occlusive hydrocellular dressing, covered with paraffin gauze
- Keywords
- the split-thickness skin graft （STSG） donor site, regraft, wound healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regrafted with thin split-thickness skin graftProcedure or surgery
Group A (the treatment group) were regrafted with thin split-thickness skin graft
covered with the occlusive hydrocellular dressingProcedure or surgery
group B covered with the occlusive hydrocellular dressing (Allevyn Adhesive, Smith \& Nephew)
covered with paraffin gauzeProcedure or surgery
Group C covered with paraffin gauze
| Study group | Role | What they receive |
|---|---|---|
| the treatment group A | The people in treatment group were regrafted with thin split-thickness skin graft Receives: Procedure: regrafted with thin split-thickness skin graft | |
| the control group B | The group B covered with the occlusive hydrocellular dressing (Allevyn Adhesive, Smith \& Nephew) Receives: Procedure: covered with the occlusive hydrocellular dressing | |
| the control group C | Group C were covered with paraffin gauze Receives: Procedure: covered with paraffin gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of epithelialization
The time of epithelialization was observed every 3 days
Measured: up to 4 weeks
Secondary outcomes (1)
Pain sensed by the patients
Pain sensed by the patients was assessed by Wong-Baker FACES Pain Rating Scale on day 2 and 5 after surgery
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startJan 2002
- Primary completionDec 2010
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Graft DisorderStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongqian Bian, Tang-Du Hospital
- Investigators
- Yongqian Bian, doctor, Study director, specify Unaffiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974583
- Sponsor's protocol ID
- TDLL-2030130
- Status last verified
- Oct 2013
- First submitted
- 12 Sep 2013
- Last updated
- 1 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound-healing Improvement by Resurfacing Split-Thickness Skin Donor Sites With Thin Split-thickness Grafting
- ClinicalTrials.gov ID
- NCT01974583
- Acronym / sponsor ID
- TDLL-2030130
- Keywords
- the split-thickness skin graft （STSG） donor site, regraft, wound healing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 1 Nov 2013 (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.
Split-thickness skin grafting remains fundamental treatment of patients with deep burns and other traumatic injuries. However, the split-thickness skin graft (STSG) donor site dressing has been controversial until now. Our study here aimed to assess patient comfort and wound-healing efficacy with the application of thin split-thickness grafting on STSG donor sites.
Detailed description
Background：Split-thickness skin grafting remains fundamental treatment of patients with deep burns and other traumatic injuries. However, the split-thickness skin graft (STSG) donor site dressing has been controversial until now. Our study here aimed to assess patient comfort and wound-healing efficacy with the application of thin split-thickness grafting on STSG donor sites.
Methods: 192 consecutive patients undergoing split-thickness skin grafting were included in the study and the participants were randomly divided into three groups: Group A was regrafted with thin STSG, while, Group B and Group C were covered with the occlusive hydrocellular dressing and paraffin gauze, respectively. The three groups were compared regarding to the time of epithelialization, pain sensed by the patients and the scar formation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the treatment group A | – | Procedure: regrafted with thin split-thickness skin graftThe people in treatment group were regrafted with thin split-thickness skin graft |
| the control group B | – | Procedure: covered with the occlusive hydrocellular dressingThe group B covered with the occlusive hydrocellular dressing (Allevyn Adhesive, Smith \& Nephew) |
| the control group C | – | Procedure: covered with paraffin gauzeGroup C were covered with paraffin gauze |
Who may qualify
- Ages
- 5 to 56 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study cohort included 192 participants, who were randomly selected from patients who continuously received an STSG from January 2002 to December 2010 in Department of Burn and Plastic Surgery, Tangdu Hospital, Fourth Military Medical University.
Key inclusion criteria (1 listed)
- patients who continuously received an STSG from January 2002 to December 2010 in Department of Burn and Plastic Surgery, Tangdu Hospital, Fourth Military Medical University
Key exclusion criteria (1 listed)
- The patients who were significant psychiatric, hypersensitive to silver, and not be followed up were excluded
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 |
|---|---|---|
| regrafted with thin split-thickness skin graftGroup A (the treatment group) were regrafted with thin split-thickness skin graft | Procedure or surgery | the treatment group A |
| covered with the occlusive hydrocellular dressinggroup B covered with the occlusive hydrocellular dressing (Allevyn Adhesive, Smith \& Nephew) | Procedure or surgery | the control group B |
| covered with paraffin gauzeGroup C covered with paraffin gauze | Procedure or surgery | the control group C |
Primary outcome
The time of epithelialization
Time frame: up to 4 weeks
The time of epithelialization was observed every 3 days
1 secondary outcome
Pain sensed by the patients
Time frame: up to 6 months
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 1 Nov 2013.
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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.
Yongqian Bian, doctor study director
specify Unaffiliated
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Graft Disorder and Disorder of Skin Donor Site, run by Tang-Du Hospital.
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 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The time of epithelialization (time frame: up to 4 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 1 Nov 2013.