Skin Regrafting; Donor Site of Skin Grafting; Vancouver Scar ScaleNCT05371171
Management of Skin Graft Donor Site Wound in Aged Patient
A study testing skin graft and no skin graft in people with Skin Regrafting; Donor Site of Skin Grafting; Vancouver Scar Scale, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
The complication of donor site in skin grafting often acts as a causing factor for extended treatment period. The elderly individuals tend to be afflicted by impaired wound healing. Herein, the investigators presented the outcome of skin regrafting in the elderly patients. Read more about this study
- Who is it for?
- Ages 60 to 99 months
- Conditions the study is for
- Skin Regrafting; Donor Site of Skin Grafting; Vancouver Scar Scale
- What is being tested?
- skin graft and no skin graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Mar 2018to 3 Sep 2019
- 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 60 to 99 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patient who need to perform skin grafting surgery
Who cannot join
- All patient who cannot be half or general anesthetized
- severe comorbidities
Trial locations and contacts
1 site in 1 country.
About this study
The complication of donor site in skin grafting often acts as a causing factor for extended treatment period. The elderly individuals tend to be afflicted by impaired wound healing. Herein, the investigators presented the outcome of skin regrafting in the elderly patients.
- Being tested
- skin graft, no skin graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin graftProcedure or surgery
In the experimental group, the operative plan was to consider taking a 15% larger amount than necessary and replace over-harvested skin back onto the donor site in an island manner. Any remaining skin graft was returned to the donor site and a polyurethane dressing [Alleyvn, Smith, \& Nephew] was placed on the regrafted skin for fixation
no skin graftProcedure or surgery
In the experimental group, the operative plan was to consider taking a 15% larger amount than necessary and replace over-harvested skin back onto the donor site in an island manner. Any remaining skin graft was returned to the donor site and a polyurethane dressing [Alleyvn, Smith, \& Nephew] was placed on the regrafted skin for fixation
| Study group | Role | What they receive |
|---|---|---|
| skin graft | Experimental | Not described Receives: Procedure: skin graft |
| no skin graft | Placebo comparator | Not described Receives: Procedure: no skin graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing time
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start13 Mar 2018
- Primary completion24 May 2019
- Study completion3 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Regrafting; Donor Site of Skin Grafting; Vancouver Scar ScaleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371171
- Sponsor's protocol ID
- N201801010
- Status last verified
- Feb 2022
- First submitted
- 24 Feb 2022
- Last updated
- 12 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Skin Graft Donor Site Wound in Aged Patient
- ClinicalTrials.gov ID
- NCT05371171
- Acronym / sponsor ID
- N201801010
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 12 May 2022 (actual)
- 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 complication of donor site in skin grafting often acts as a causing factor for extended treatment period. The elderly individuals tend to be afflicted by impaired wound healing. Herein, the investigators presented the outcome of skin regrafting in the elderly patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| skin graft | Experimental | Procedure: skin graft |
| no skin graft | Placebo comparator | Procedure: no skin graft |
Who may qualify
- Ages
- 60 to 99 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All patient who need to perform skin grafting surgery
Key exclusion criteria (2 listed)
- All patient who cannot be half or general anesthetized
- severe comorbidities
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 |
|---|---|---|
| skin graftIn the experimental group, the operative plan was to consider taking a 15% larger amount than necessary and replace over-harvested skin back onto the donor site in an island manner. Any remaining skin graft was returned to the donor site and a polyurethane dressing [Alleyvn, Smith, \& Nephew] was placed on the regrafted skin for fixation | Procedure or surgery | skin graft |
| no skin graftIn the experimental group, the operative plan was to consider taking a 15% larger amount than necessary and replace over-harvested skin back onto the donor site in an island manner. Any remaining skin graft was returned to the donor site and a polyurethane dressing [Alleyvn, Smith, \& Nephew] was placed on the regrafted skin for fixation | Procedure or surgery | no skin graft |
Primary outcome
healing time
Time frame: three 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 12 May 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin graft and no skin graft in people with Skin Regrafting; Donor Site of Skin Grafting; Vancouver Scar Scale, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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: finished, as of the sponsor's last update on 12 May 2022. 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 Taiwan. 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.
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?
healing time (time frame: three months). 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 12 May 2022.