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

NCT ID: NCT07257991

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Skin Graft Wounds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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PG GROUP

Paraffin gauze dressing will be used.

Group Type ACTIVE_COMPARATOR

Paraffin mesh gauze dressing for donor site of Split-thickness skin graft

Intervention Type PROCEDURE

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.

PI GROUP

Povidone-iodine foam dressing will be used in this group.

Group Type EXPERIMENTAL

Povidine-iodine foam dressing for donor site of Split-thickness skin graft

Intervention Type PROCEDURE

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.

Interventions

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Povidine-iodine foam dressing for donor site of Split-thickness skin graft

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.

Intervention Type PROCEDURE

Paraffin mesh gauze dressing for donor site of Split-thickness skin graft

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Undergoing skin graft with donor site size between 25 to 200 cm2

Exclusion Criteria

* Patients wit history of disease impairing wound healing (Diabetes, Malignancy, Cancer, taking immunosuppressants)
* Pregnant or lactating females
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shaheed Mohtarma Benazir Bhutto Institue of Trauma

OTHER

Sponsor Role lead

Responsible Party

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Saba Asif

Postgraduate Trainee

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 30479060 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/30479060/

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

Other Identifiers

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IRB000195/SMBBIT/Approval/2025

Identifier Type: -

Identifier Source: org_study_id

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