Topical Heparin for Prevention of Hypertrophic Scarring in Split-Thickness Skin Graft Donor Sites

NCT ID: NCT07196358

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2025-09-10

Brief Summary

This study is testing whether applying a special dressing soaked with heparin (a medicine that improves blood flow and reduces scar formation) can help prevent thick, raised scars (called hypertrophic scars) and reduce pain at the site where skin is taken for a split-thickness skin graft. When people need skin grafts for burns, injuries, or other conditions, the area where the skin is taken (donor site) can sometimes heal with painful or raised scars. In this study, each patient will have one donor site treated with the standard dressing and the other site treated with heparin dressing. We will compare how the wounds heal, the amount of pain, and whether scars develop over a 3-month period. The goal is to see if this simple, low-cost method can improve healing and reduce scarring for patients needing skin grafts.

Detailed Description

Hypertrophic scarring at the donor site of split-thickness skin grafts (STSG) is a common problem that can cause pain, itching, discomfort, and cosmetic concerns. Conventional donor site dressings allow healing but do not specifically address scar prevention. Heparin has anti-inflammatory and anti-fibrotic properties, improves local blood circulation, and may reduce the formation of raised scars. Previous research has suggested a role for topical heparin in burn wound management, but its effect on STSG donor sites has not been adequately studied.

This study is an open-label, randomized controlled trial conducted in the Plastic & Reconstructive Surgery Department at Ruth Pfau Civil Hospital, Dow University of Health Sciences. A total of 200 patients requiring STSG will be enrolled. Each patient will provide two donor sites (both thighs). One site will receive the standard paraffin gauze dressing, while the other will receive a heparin-soaked gauze dressing prepared by diluting heparin 5000 IU/mL with saline to achieve a 500 IU/mL solution. Dressings will remain in place until postoperative day 10 unless earlier change is required.

The primary outcome is the incidence and severity of hypertrophic scarring at the donor site, assessed using the Vancouver Scar Scale at 3 months. Secondary outcomes include donor site pain (measured by Numeric Rating Scale), analgesic requirements, and wound complications. Patients will be followed up at day 10, 1 month, and 3 months.

The study aims to determine whether topical heparin is an inexpensive, safe, and effective method to improve healing and prevent hypertrophic scarring in resource-limited settings, potentially changing standard practice for donor site management.

Conditions

Hypertrophic Scarring; Pain, Postoperative; Wound Healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm 1: Standard Dressing

Description: Donor site of STSG treated with standard dressing (paraffin gauze, gauze pieces, bandaged) as per hospital protocol. Dressing removed on 10th post-operative day unless clinically indicated earlier.

Group Type: ACTIVE_COMPARATOR

Standard dressing

Intervention Type: OTHER

Intervention Description: Donor site of STSG treated with standard dressing. Wound is cleaned, paraffin gauze applied, covered with gauze pieces and bandaged. Dressing is removed on the 10th post-operative day, or earlier if excessive exudate is present. Pain and wound healing monitored per standard care protoco

Heparin Dressing

Description: Donor site of STSG treated with heparin-soaked gauze (5 ml 5000 IU/ml heparin diluted in 50 ml saline to 500 IU/ml concentration) applied immediately post-harvest, dressing left in place till 10th post-operative day unless clinically indicated earlier.

Group Type: EXPERIMENTAL

Topical Heparin Dressing

Intervention Type: OTHER

Intervention Description: Donor site of STSG treated with heparin dressing. 5 ml of 5000 IU/ml heparin is diluted in 50 ml normal saline to produce 500 IU/ml concentration. Gauze is soaked in this solution and applied to donor site immediately after graft harvest. Dressing remains in place until 10th post-operative day unless clinical indication requires earlier change. Pain, wound healing, and hypertrophic scarring assessed during follow-up.

Interventions

Standard dressing

Intervention Description: Donor site of STSG treated with standard dressing. Wound is cleaned, paraffin gauze applied, covered with gauze pieces and bandaged. Dressing is removed on the 10th post-operative day, or earlier if excessive exudate is present. Pain and wound healing monitored per standard care protoco

Intervention Type: OTHER

Topical Heparin Dressing

Intervention Description: Donor site of STSG treated with heparin dressing. 5 ml of 5000 IU/ml heparin is diluted in 50 ml normal saline to produce 500 IU/ml concentration. Gauze is soaked in this solution and applied to donor site immediately after graft harvest. Dressing remains in place until 10th post-operative day unless clinical indication requires earlier change. Pain, wound healing, and hypertrophic scarring assessed during follow-up.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients of age 2 years and above, of any gender.

Patients requiring a split-thickness skin graft.

Patients giving informed consent for study participation.

Patients with serum albumin > 3 g/dL.

Exclusion Criteria

• Patients allergic to heparin.

Patients with diabetes, hematological disorders, kidney or liver diseases, or malignancies.

Patients on medications affecting wound healing.

Patients with existing hypertrophic scarring at the donor site

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Ruth K.M. Pfau Civil Hospital, Karachi

OTHER_GOV

Sponsor Role: lead

Responsible Party

Asma Ishtiaq

DR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Plastic & Reconstructive Surgery Department, Ruth Pfau Civil Hospita

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

IRB-3459-DUHS/Approval-2024-18

Identifier Type: OTHER

Identifier Source: secondary_id

DUHS-185

Identifier Type: -

Identifier Source: org_study_id