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

NCT07196358 | Completed DMC

• 2 other identifiers: DUHS-185IRB-3459-DUHS/Approval-2024-18
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Scarring; Pain, Postoperative; Wound Healing

Keywords

Hypertrophic Scar Split-Thickness Skin Graft (STSG) Donor Site Wound Healing Topical Heparin Scar Prevention Vancouver Scar Scale Pain Management

Outcome Measures

Primary Outcomes (1)

• Incidence of hypertrophic scarring at STSG donor site

  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.

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

Secondary Outcomes (1)

• Donor site pain

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

Study Arms (2)

Arm 1: Standard Dressing

ACTIVE COMPARATOR

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.

Other: Standard dressing

Heparin Dressing

EXPERIMENTAL

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.

Other: Topical Heparin Dressing

Interventions

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

Arm 1: Standard Dressing

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.

Heparin Dressing

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Ruth K.M. Pfau Civil Hospital, Karachi: lead

Study Sites (1)

Plastic & Reconstructive Surgery Department, Ruth Pfau Civil Hospita

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic; Pain, Postoperative

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Model Details: This is an open-label, parallel-group randomized controlled trial. Participants will act as their own controls, with one thigh receiving a heparin-soaked dressing (intervention) and the other thigh receiving the standard dressing (control). This design allows for direct comparison of hypertrophic scarring and pain outcomes at donor sites under different dressing protocols while controlling for individual patient variability. The intervention will be applied immediately after split-thickness skin graft harvesting and maintained according to the study protocol.

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: September 29, 2025
• Study Start: August 15, 2024
• Primary Completion: August 30, 2025
• Study Completion: September 10, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)