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

Official title

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

Overview

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.

Detailed description

Chronic wounds are a common problem, particularly in patients with diabetes, vascular diseases, or post-traumatic injuries, and are associated with significant pain, delayed healing, and increased healthcare costs. Pain in chronic wounds can be both background and procedural, affecting quality of life and sometimes leading to psychosocial complications. Current treatments include surgical and non-surgical interventions, such as tulle dressings, interactive dressings, skin substitutes, and negative pressure wound therapy. However, these approaches may be costly, require frequent dressing changes, or have limited availability, particularly in lower-middle-income countries.

Autologous fat grafting has emerged as a promising technique to promote wound healing due to the high content of stem cells and growth factors in adipose tissue. Recent studies suggest that fat grafting not only accelerates tissue regeneration but may also reduce pain associated with chronic wounds. Limited data exist regarding its efficacy specifically for pain reduction in chronic wounds.

This randomized controlled trial will enroll 62 adult patients (ages 20-60) with chronic wounds persisting for more than 3 months and with a baseline mean VAS pain score \>3. Participants will be randomly assigned to one of two groups: Group A (fat grafting plus standard wound care) or Group B (standard wound care alone). Wound cleansing will be performed in both groups using povidone-iodine. In Group A, autologous fat will be harvested using the Coleman technique, processed into nano-fat through sequential filtering and centrifugation, and injected into the wound bed and margins. In Group B, wounds will be managed with standard tulle gauze dressings. Dressings in both groups will be changed every 48-72 hours.

Pain will be assessed using the Visual Analog Scale three times daily for 21 days, and the mean daily pain score will be calculated. Wound healing percentage, wound size, and any complications, including infection, will be documented. Rescue analgesia (IV Toradol 0.5 mg/kg) will be provided if the VAS score exceeds 3. Data will be analyzed using SPSS v26, with appropriate statistical tests applied to compare pain reduction and wound healing between groups.

The study aims to provide evidence on the effectiveness and safety of autologous fat grafting for reducing pain and improving outcomes in patients with chronic wounds, potentially informing future clinical practice and management strategies for this patient population.

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
• 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.

Primary outcome measures

• Reduction in Mean Pain Score in Patients With Chronic Wounds [Time frame: 21 days post-treatment]

Eligibility criteria

Inclusion criteria

• • 3 months old chronic wound (Venous arterial, traumatic, burn and diabetic) having mean VAS Pain score >3 at rest

• Wound area between 4 cm² to 10 cm²
• Aged 20-60 years.
• Both male and female

Exclusion criteria

• • Active wound infection.

• Wounds due to malignancy or irradiation.
• Pregnant or lactating females
• Smokers

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07480447 · 21/RC/KEMU · 21/RC/KEMU

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗