Skin Graft WoundsNCT07257991
Comparison of Dressing Materials of Donor Site of Split-thickness Skin Graft; Paraffin Mesh Gauze vs Povidone-Iodine Foam at SMBB Institute of Trauma Karachi
A study testing Povidine-iodine foam dressing for donor site of Split-thickness skin graft and Paraffin mesh gauze dressing for donor site of Split-thickness skin graft in people with Skin Graft Wounds, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma.
Trial summary
The goal of this clinical trial is to learn if povidone-iodine foam dressing is better in achieving complete reepithelialization of donor site wounds after harvest of split-thickness skin graft as paraffin mesh gauze. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Graft Wounds
- What is being tested?
- Povidine-iodine foam dressing for donor site of Split-thickness skin graft and Paraffin mesh gauze dressing for donor site of Split-thickness skin graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing skin graft with donor site size between 25 to 200 cm2
Who cannot join
- Patients wit history of disease impairing wound healing (Diabetes, Malignancy, Cancer, taking immunosuppressants)
- Pregnant or lactating females
About this study
The goal of this clinical trial is to learn if povidone-iodine foam dressing is better in achieving complete reepithelialization of donor site wounds after harvest of split-thickness skin graft as paraffin mesh gauze.
The main questions it aims to answer are:
Read more
Does povidone-iodine foam dressing promotes complete reepithelialization earlier in comparison? Which type of dressing will require fewer replacements? Which type of dressing material is associated with less pain?
Non-probability consecutive sampling method will be used and participants divided in two groups. Donor site wounds after split-thickness skin graft harvest will be dressed using two different dressing materials. Participants will be followed until complete epithelialization with change of dressing on follow-ups if required. Complete epithelialization is usually achieved within two weeks.
- Conditions
- Skin Graft Wounds
- Being tested
- Povidine-iodine foam dressing for donor site of Split-thickness skin graft, Paraffin mesh gauze dressing for donor site of Split-thickness skin graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidine-iodine foam dressing for donor site of Split-thickness skin graftProcedure or surgery
A sterile, medical-grade open-cell polyurethane foam will be cut to fit the split-thickness skin graft donor site and soaked in 3% povidone-iodine solution immediately before application. The foam dressing will be applied to the donor site under aseptic conditions and secured with a sterile secondary dressing of gauze and crepe bandage.
The initial dressing will be left undisturbed for 7 days unless early change is required due to bleeding, leakage, loosening, or signs of infection. The donor site will first be assessed on day 7, and subsequently every alternate day until complete re-epithelialization. At each assessment, the dressing will be changed only if clinically indicated.
Paraffin mesh gauze dressing for donor site of Split-thickness skin graftProcedure or surgery
A sterile paraffin-impregnated mesh gauze dressing will be applied directly over the donor site under aseptic conditions. The dressing will be covered with sterile secondary gauze and secured with crepe bandage. The initial dressing will be left undisturbed for 7 days unless early change is required for bleeding, leakage, or infection. The donor site will be assessed on day 7 and every alternate day thereafter until complete re-epithelialization, and the dressing will be changed only if clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| PG GROUP | Active comparator | Paraffin gauze dressing will be used. Receives: Procedure: Paraffin mesh gauze dressing for donor site of Split-thickness skin graft |
| PI GROUP | Experimental | Povidone-iodine foam dressing will be used in this group. Receives: Procedure: Povidine-iodine foam dressing for donor site of Split-thickness skin graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with complete reepithelialization at day 14
Measurement name is percentage of patients. Measurement tool will be clinical observation/ visual assessment by principal investigator defined as 100% wound healing.
Measured: From the day of procedure till complete reepithelialization, nearly 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin Graft WoundsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of Trauma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saba Asif, Shaheed Mohtarma Benazir Bhutto Institue of Trauma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257991
- Sponsor's protocol ID
- IRB000195/SMBBIT/Approval/2025
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pak CS, Park DH, Oh TS, Lee WJ, Jun YJ, Lee KA, Oh KS, Kwak KH, Rhie JW. Comparison of the efficacy and safety of povidone-iodine foam dressing (Betafoam), hydrocellular foam dressing (Allevyn), and petrolatum gauze for split-thickness skin graft donor site dressing. Int Wound J. 2019 Apr;16(2):379-386. doi: 10.1111/iwj.13043. Epub 2018 Nov 26.
PubMed 30479060
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dressing Materials of Donor Site of Split-thickness Skin Graft; Paraffin Mesh Gauze vs Povidone-Iodine Foam at SMBB Institute of Trauma Karachi
- ClinicalTrials.gov ID
- NCT07257991
- Acronym / sponsor ID
- IRB000195/SMBBIT/Approval/2025
- Conditions
- Skin Graft Wounds
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of TraumaUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 2 Dec 2025 (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 goal of this clinical trial is to learn if povidone-iodine foam dressing is better in achieving complete reepithelialization of donor site wounds after harvest of split-thickness skin graft as paraffin mesh gauze.
The main questions it aims to answer are:
Does povidone-iodine foam dressing promotes complete reepithelialization earlier in comparison? Which type of dressing will require fewer replacements? Which type of dressing material is associated with less pain?
Non-probability consecutive sampling method will be used and participants divided in two groups. Donor site wounds after split-thickness skin graft harvest will be dressed using two different dressing materials. Participants will be followed until complete epithelialization with change of dressing on follow-ups if required. Complete epithelialization is usually achieved within two weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PG GROUP | Active comparator | Procedure: Paraffin mesh gauze dressing for donor site of Split-thickness skin graftParaffin gauze dressing will be used. |
| PI GROUP | Experimental | Procedure: Povidine-iodine foam dressing for donor site of Split-thickness skin graftPovidone-iodine foam dressing will be used in this group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing skin graft with donor site size between 25 to 200 cm2
Key exclusion criteria (2 listed)
- Patients wit history of disease impairing wound healing (Diabetes, Malignancy, Cancer, taking immunosuppressants)
- Pregnant or lactating females
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 |
|---|---|---|
| Povidine-iodine foam dressing for donor site of Split-thickness skin graftA sterile, medical-grade open-cell polyurethane foam will be cut to fit the split-thickness skin graft donor site and soaked in 3% povidone-iodine solution immediately before application. The foam dressing will be applied to the donor site under aseptic conditions and secured with a sterile secondary dressing of gauze and crepe bandage. The initial dressing will be left undisturbed for 7 days unless early change is required due to bleeding, leakage, loosening, or signs of infection. The donor site will first be assessed on day 7, and subsequently every alternate day until complete re-epithelialization. At each assessment, the dressing will be changed only if clinically indicated. | Procedure or surgery | PI GROUP |
| Paraffin mesh gauze dressing for donor site of Split-thickness skin graftA sterile paraffin-impregnated mesh gauze dressing will be applied directly over the donor site under aseptic conditions. The dressing will be covered with sterile secondary gauze and secured with crepe bandage. The initial dressing will be left undisturbed for 7 days unless early change is required for bleeding, leakage, or infection. The donor site will be assessed on day 7 and every alternate day thereafter until complete re-epithelialization, and the dressing will be changed only if clinically indicated. | Procedure or surgery | PG GROUP |
Primary outcome
Percentage of patients with complete reepithelialization at day 14
Time frame: From the day of procedure till complete reepithelialization, nearly 14 days
Measurement name is percentage of patients. Measurement tool will be clinical observation/ visual assessment by principal investigator defined as 100% wound healing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Background: PubMed 30479060Pak CS, Park DH, Oh TS, Lee WJ, Jun YJ, Lee KA, Oh KS, Kwak KH, Rhie JW. Comparison of the efficacy and safety of povidone-iodine foam dressing (Betafoam), hydrocellular foam dressing (Allevyn), and petrolatum gauze for split-thickness skin graft donor site dressing. Int Wound J. 2019 Apr;16(2):379-386. doi: 10.1111/iwj.13043. Epub 2018 Nov 26.
- Comparison of the efficacy and safety of povidone-iodine foam dressing (Betafoam), hydrocellular foam dressing (Allevyn), and petrolatum gauze for split-thickness skin graft donor site dressingLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Povidine-iodine foam dressing for donor site of Split-thickness skin graft and Paraffin mesh gauze dressing for donor site of Split-thickness skin graft in people with Skin Graft Wounds, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma.
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: opening soon, as of the sponsor's last update on 15 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of patients with complete reepithelialization at day 14 (time frame: From the day of procedure till complete reepithelialization, nearly 14 days). 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 NCT07257991, which also lists 1 linked publication.
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 15 Dec 2025.