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NOT YET RECRUITING
NCT07480447
NA

Comparison of Pain Reduction in Painful Chronic Wounds With and Without Fat Grafting

Sponsor: King Edward Medical University

View on ClinicalTrials.gov

Summary

Chronic wounds, such as those caused by diabetes, burns, or poor blood circulation, often heal slowly and can cause significant pain, affecting daily life and quality of life. This study aims to evaluate whether autologous fat grafting-a procedure in which a patient's own fat tissue is injected into the wound-can reduce pain and improve healing in chronic wounds compared to standard care without fat grafting. We will enroll 62 adult patients with chronic wounds lasting more than 3 months. Participants will be randomly assigned to two groups: one group will receive fat grafting along with standard wound care, and the other group will receive standard wound care alone. Pain will be measured using a Visual Analog Scale (VAS) over 21 days after treatment. Wound healing and any complications will also be monitored. The results of this study will help determine if autologous fat grafting is an effective and safe method to reduce pain and improve recovery in patients with chronic wounds.

Official title: Comparison of Pain Reduction in Chronic Wounds Treated With and Without Autologous Fat Grafting: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

20 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2026-05-01

Completion Date

2026-11-01

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

PROCEDURE

Autologous Fat Grafting

Participants will receive autologous fat grafting in addition to standard wound care. Fat will be harvested from the patient's thigh using the Coleman technique, processed into nano-fat through sequential filtering and centrifugation, and injected into the wound bed and margins. The injection volume is approximately 0.4 cc per cm² along wound edges and 0.6 cc per cm² within the wound bed. After injection, wounds will be dressed with tulle gauze, with dressing changes every 48-72 hours. Pain will be assessed using the Visual Analog Scale (VAS) three times daily for 21 days. Wound size, healing percentage, and complications, including infection, will also be monitored. Rescue analgesia (IV Toradol 0.5 mg/kg) will be administered if VAS \> 3.

PROCEDURE

Standard Wound Care

Participants will receive standard wound care without fat grafting. Wounds will be cleaned with povidone-iodine and dressed with tulle gauze and a secondary cotton gauze layer. Dressing changes will occur every 48-72 hours. Pain will be assessed using the VAS three times daily for 21 days. Wound size, healing percentage, and complications, including infection, will also be monitored. Rescue analgesia (IV Toradol 0.5 mg/kg) will be administered if VAS \>3.