Traumatic Skin Loss, 2nd and 3rd Degree Burn, Post Tumour Excision - Raw Areas Undergoes Split- Thickness Skin GraftsNCT06488612
Evaluation of the Use of Minced Skin Grafts for Promoting Donor Site Wound Healing After Split-Thickness Skin Grafting
A study testing Minced skin grafts for donor site in people with Traumatic Skin Loss, 2nd and 3rd Degree Burn, Post Tumour Excision - Raw Areas Undergoes Split- Thickness Skin Grafts, run by Sohag University at 1 site in Egypt.
Trial summary
Split-thickness skin grafting (STSG) is one of the most commonly performed procedures to achieve wound closure. Most studies are concerned on improving the appearance of scars and shortening the healing time of the recipient sites. However, the management of the donor site usually takes a second consideration. Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Skin Loss, 2nd and 3rd Degree Burn, Post Tumour Excision - Raw Areas Undergoes Split- Thickness Skin Grafts
- What is being tested?
- Minced skin grafts for donor site
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Dec 2024
- 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 12 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All patients undergoing split-thickness skin grafting, between 12 - 60 years of age.
Who cannot join
- Patients under the age of 12 years or above 60 years.
- Patients with a known tendency for hypertrophic scarring/keloids
- Pregnancy
- Co-morbid factors such as uncontrolled diabetes, ischemic heart disease, renal failure or Collagen vascular disease.
Trial locations and contacts
1 site in 1 country.
Mohamed Abd Elmawla Mohamed, Resident plastic surgeon contact
Gamal Yousef Elsayed, Professor of plastic surgery contact
Egypt1 site, 1 recruiting
- Recruiting
Plastic surgery department, Faculty of medicine, Sohag university
Sohag, 02093
Mohamed Abd El-Mawla Mohamed, Resident plastic surgeon, +0201221953861, mohamed_abdelmageed@med.sohag.edu.eg
Gamal Yousef Elsayed, Professor of plastic surgery, +20 115 6996929
About this study
Official title: Evaluation of the Use of Minced Skin Grafts for Promoting Donor Site Wound Healing After Split-Thickness Skin Grafting: A Prospective Half-side Comparative Study
Split-thickness skin grafting (STSG) is one of the most commonly performed procedures to achieve wound closure. Most studies are concerned on improving the appearance of scars and shortening the healing time of the recipient sites. However, the management of the donor site usually takes a second consideration.
There is a lack of consensus on the recommended method of donor site management. Donor site morbidity of STSG is usually minimal, but that may not always be the case. Morbidity may include pigmentary abnormalities, prolonged pain and itching, delayed healing, or unfavorable scarring. So, an effort must be taken to find the optimal solution for donor site healing and minimize morbidity.
Small portions of the skin graft left at the end of the procedure or the graft pieces obtained after trimming the edges are usually discarded. There have been some studies demonstrating the benefit of the minced residual skin graft on the donor site, possibly resulting in earlier epithelialization and improving the appearance
Read the detailed description
The aim of this study is to compare the duration of wound healing, scar quality and cosmetic results of donor sites after split-thickness skin grafting with and without the use of residual graft pieces as minced skin grafts.
- Being tested
- Minced skin grafts for donor site
- Keywords
- Split- thickness Skin grafting
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minced skin grafts for donor siteProcedure or surgery
After harvesting of STSG using watson's knife and coverage of the recipient site, the excess graft edges will be trimmed and together with any unused graft pieces will be collected in saline filled plate to prevent graft dissecation. Graft pieces will be placed over a rigid surface such as dorsum of a stainless steal jar or pot. Mincing of these small grafts will be done manually using large blade (no. 25) and sharp scissors. The resulting pasty graft mass composed of a large number of minced skin graft particles and a small amount of saline solution will be spread onto one half of the donor site using small dressing forceps.
Minced skin grafts will not be used on the other half (control side). The entire donor site will be covered with non-adherent absorbable dressing in the form of Vaseline gauze and sterilized cotton-filled dressing followed by elastic compression bandage.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Experimental | A Prospective Half-side Comparative Study, Minced skin grafts will be used on a half of donor site of the same patient Receives: Procedure: Minced skin grafts for donor site |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar quality
using POSAS scale.
- Patient Observer Scar Assesment Scale (POSAS) is a validated scale that measures scar quality by evaluating visual, tactile, and sensory characteristics of the scar from two different perspectives: the patient perspective and the surgeons' perspective.
Measured: Follow up at 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Dec 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Skin Loss, 2nd and 3rd Degree Burn, Post Tumour Excision - Raw Areas Undergoes Split- Thickness Skin GraftsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelmawla Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488612
- Sponsor's protocol ID
- Soh-Med-24-02-09MS
- Status last verified
- Jul 2024
- First submitted
- 15 Mar 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final results
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Minced Skin Grafts for Promoting Donor Site Wound Healing After Split-Thickness Skin Grafting: A Prospective Half-side Comparative Study
- ClinicalTrials.gov ID
- NCT06488612
- Acronym / sponsor ID
- Soh-Med-24-02-09MS
- Keywords
- Split- thickness Skin grafting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 5 Jul 2024 (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.
Split-thickness skin grafting (STSG) is one of the most commonly performed procedures to achieve wound closure. Most studies are concerned on improving the appearance of scars and shortening the healing time of the recipient sites. However, the management of the donor site usually takes a second consideration.
There is a lack of consensus on the recommended method of donor site management. Donor site morbidity of STSG is usually minimal, but that may not always be the case. Morbidity may include pigmentary abnormalities, prolonged pain and itching, delayed healing, or unfavorable scarring. So, an effort must be taken to find the optimal solution for donor site healing and minimize morbidity.
Small portions of the skin graft left at the end of the procedure or the graft pieces obtained after trimming the edges are usually discarded. There have been some studies demonstrating the benefit of the minced residual skin graft on the donor site, possibly resulting in earlier epithelialization and improving the appearance
Detailed description
The aim of this study is to compare the duration of wound healing, scar quality and cosmetic results of donor sites after split-thickness skin grafting with and without the use of residual graft pieces as minced skin grafts.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | Experimental | Procedure: Minced skin grafts for donor siteA Prospective Half-side Comparative Study, Minced skin grafts will be used on a half of donor site of the same patient |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All patients undergoing split-thickness skin grafting, between 12 - 60 years of age.
Key exclusion criteria (4 listed)
- Patients under the age of 12 years or above 60 years.
- Patients with a known tendency for hypertrophic scarring/keloids
- Pregnancy
- Co-morbid factors such as uncontrolled diabetes, ischemic heart disease, renal failure or Collagen vascular disease.
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 |
|---|---|---|
| Minced skin grafts for donor siteAfter harvesting of STSG using watson's knife and coverage of the recipient site, the excess graft edges will be trimmed and together with any unused graft pieces will be collected in saline filled plate to prevent graft dissecation. Graft pieces will be placed over a rigid surface such as dorsum of a stainless steal jar or pot. Mincing of these small grafts will be done manually using large blade (no. 25) and sharp scissors. The resulting pasty graft mass composed of a large number of minced skin graft particles and a small amount of saline solution will be spread onto one half of the donor site using small dressing forceps. Minced skin grafts will not be used on the other half (control side). The entire donor site will be covered with non-adherent absorbable dressing in the form of Vaseline gauze and sterilized cotton-filled dressing followed by elastic compression bandage. | Procedure or surgery | Cases |
Primary outcome
Scar quality
Time frame: Follow up at 1 month, 3 months, 6 months
using POSAS scale. • Patient Observer Scar Assesment Scale (POSAS) is a validated scale that measures scar quality by evaluating visual, tactile, and sensory characteristics of the scar from two different perspectives: the patient perspective and the surgeons' perspective.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: Yes. Final results
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.
Mohamed Abd Elmawla Mohamed, Resident plastic surgeon contact
Gamal Yousef Elsayed, Professor of plastic surgery contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minced skin grafts for donor site in people with Traumatic Skin Loss, 2nd and 3rd Degree Burn, Post Tumour Excision - Raw Areas Undergoes Split- Thickness Skin Grafts, run by Sohag University at 1 site in Egypt.
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 4 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: status not confirmed, as of the sponsor's last update on 5 Jul 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Abd Elmawla Mohamed, Resident plastic surgeon (+0201221953861, mohamed_abdelmageed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar quality (time frame: Follow up at 1 month, 3 months, 6 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 5 Jul 2024.