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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShaheed Mohtarma Benazir Bhutto Institue of Trauma

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Patients wit history of disease impairing wound healing (Diabetes, Malignancy, Cancer, taking immunosuppressants)

Pregnant or lactating females

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/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 graft

    Procedure/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.

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: PG GROUPActive comparator 1 intervention
Group B: PI GROUPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From the day of procedure till complete reepithelialization, nearly 14 days

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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