- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05371171
Management of Skin Graft Donor Site Wound in Aged Patient
May 10, 2022 updated by: Taipei Medical University WanFang Hospital
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
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
-
-
-
Taipei county, Taiwan
- Wan Fang Hospital
-
-
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
5 years to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All patient who need to perform skin grafting surgery
Exclusion Criteria:
- All patient who cannot be half or general anesthetized
- severe comorbidities
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: skin graft
|
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
|
|
Placebo Comparator: no skin graft
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
healing time
Time Frame: three months
|
three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
March 13, 2018
Primary Completion (Actual)
May 24, 2019
Study Completion (Actual)
September 3, 2019
Study Registration Dates
First Submitted
February 24, 2022
First Submitted That Met QC Criteria
May 10, 2022
First Posted (Actual)
May 12, 2022
Study Record Updates
Last Update Posted (Actual)
May 12, 2022
Last Update Submitted That Met QC Criteria
May 10, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- N201801010
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.