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

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

Status: Completed

Conditions: Hypertrophic Scarring; Wound Healing; Pain, Postoperative

Treatments: Other: Standard dressing; Other: Topical Heparin Dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT07196358

DUHS-185

IRB-3459-DUHS/Approval-2024-18 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Arm 1: Standard Dressing

Active Comparator group

Description:

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.

Treatment:

Other: Standard dressing

Heparin Dressing

Experimental group

Description:

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.

Treatment:

Other: Topical Heparin Dressing