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临床试验/NCT07480447
NCT07480447尚未招募不适用

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

King Edward Medical University0 个研究点目标入组 62 人开始时间: 2026年5月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
62
主要终点
Reduction in Mean Pain Score in Patients With Chronic Wounds

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • 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

排除标准

  • • Active wound infection.
  • Wounds due to malignancy or irradiation.
  • Pregnant or lactating females

研究组 & 干预措施

Fat Grafting Plus Standard Wound Care

Experimental

Participants in this arm 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 typical volume is approximately 0.4 cc per cm² along wound edges and 0.6 cc per cm² within the wound bed. Wounds will be dressed with tulle gauze, with dressings changed every 48-72 hours. Pain, wound size, and wound healing will be monitored for 21 days, with rescue analgesia provided if VAS > 3.

干预措施: Autologous Fat Grafting (Procedure)

Standard Wound Care Alone

Active Comparator

Participants in this arm will receive standard wound care alone without fat grafting. Wounds will be cleaned with povidone-iodine and dressed with tulle gauze and cotton gauze layers. Dressings will be changed every 48-72 hours. Pain, wound size, and wound healing will be monitored for 21 days, with rescue analgesia provided if VAS >3.

干预措施: Standard Wound Care (Procedure)

结局指标

主要结局

Reduction in Mean Pain Score in Patients With Chronic Wounds

时间窗: 21 days post-treatment

Pain will be assessed using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable). The mean pain score will be calculated for each patient three times daily (8:00 am, 2:00 pm, and 8:00 pm) over the 21-day post-treatment period. The primary outcome is the change in mean VAS pain score from baseline to post-treatment in patients receiving autologous fat grafting compared to those receiving standard wound care.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Farrukh Aslam

Assosiate Professor

King Edward Medical University

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