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Not yet recruiting NCT07257991

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

No phase Interventional Skin Graft Wounds

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Povidine-iodine foam dressing for donor site of Split-thickness skin graft, Paraffin mesh gauze dressing for donor site of Split-thickness skin graft.
Who it may be relevant to
Registry conditions: Skin Graft Wounds. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure 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 s
  • 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 clinical

Primary outcome measures

  • Percentage of patients with complete reepithelialization at day 14 [Time frame: From the day of procedure till complete reepithelialization, nearly 14 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 30479060

Identifiers

NCT: NCT07257991 · IRB000195/SMBBIT/Approval/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗