Skip to main content
OpenTrials
Completed

NCT Number: NCT07196358

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertrophic Scarring Cicatrix Cicatrix, Hypertrophic Fibrosis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Wound Healing

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Plastic & Reconstructive Surgery Department, Ruth Pfau Civil Hospita

Karachi, Sindh, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard dressing

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

Topical Heparin Dressing

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.

Primary outcomes

  1. Incidence of hypertrophic scarring at STSG donor site

    Time frame: Assessed at 10th post-operative day, 1 month, and 3 months

    Hypertrophic scarring will be measured using the Vancouver Scar Scale, which evaluates vascularity, height, pliability, and pigmentation. Total score ranges from 0-13. Comparison will be made between the standard dressing and heparin dressing groups.

Secondary outcomes

  1. Donor site pain

    Time frame: 10th post-operative day, 1 month, and 3 months

    Pain will be assessed using the Numeric Rating Scale (0-10), where 0 indicates no pain and 10 indicates worst pain. Daily analgesic requirement will also be documented.

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

ROLE OF HEPARIN TO PREVENT HYPERTROPHIC SCARNIG IN DONOR AREA OF SPLIT THICKNESS SKIN GRAFT

Acronym: HepScar

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.