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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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.

Taiwan1 site

Wan Fang Hospital
Taipei County

Other trials in Taiwan

About this study

Conditions: Skin Regrafting; Donor Site of Skin Grafting; Vancouver Scar Scale
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 groups in NCT05371171
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.

13 Mar 20183 Sep 2019

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)

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
Conditions: Skin Regrafting; Donor Site of Skin Grafting; Vancouver Scar Scale
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.

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?

On the ClinicalTrials.gov record for NCT05371171.

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.