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临床试验/NCT07300137
NCT07300137Enrolling By Invitation不适用

Comparison of Outcome of Amniotic Membrane Dressing vs Sodium Carboxylic Methyl Cellulose Silver Dressing (Aquacel®Ag) in Terms of Healing in Second-Degree Burns - A Randomized Controlled Trial''

Patel Hospital, Pakistan1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
100
试验地点
1
主要终点
Healing

研究概览

简要总结

To compare the outcome of amniotic membrane dressing versus Aquacel® Ag dressing with respect to the duration of healing in patients with second-degree burns within the local demographic setting. This study aims to address the existing gap in the literature by comparing the efficacy of amniotic membrane dressing and Aquacel® Ag dressing in the management of second-degree burns. Although Aquacel® Ag has been extensively studied for partial-thickness burns, it has not been directly compared with human amniotic membrane dressing, and no randomized controlled trial has yet evaluated these two treatment modalities. The findings of this study are expected to provide healthcare providers with an effective and cost-efficient dressing option for burn patients, particularly in resource-limited countries, while minimizing morbidity.

详细描述

Burns pose a significant global health burden, particularly in low- and middle-income countries. Optimal wound care is essential to enhance healing, reduce complications, and minimize the need for surgical interventions. Human amniotic membrane dressings and silver-impregnated hydrofiber dressings such as Aquacel® Ag are commonly used options for the management of second-degree burns, each offering distinct biological properties and clinical benefits.

This randomized controlled trial aims to compare the efficacy of amniotic membrane dressing with Aquacel® Ag (sodium carboxymethylcellulose silver dressing) in terms of wound healing in patients with second-degree burns. The study will include patients presenting within 72 hours of injury with burns involving ≤40% total body surface area (TBSA). A total of 100 participants will be enrolled using non-probability convenience sampling and randomized through a computer-generated method into two groups. Group A will receive amniotic membrane dressings, while Group B will be treated with Aquacel® Ag dressings.

In Group A, dressings will be changed every 72 hours. In Group B, secondary dressings will be changed and the wound will be reviewed for soakage or gross contamination, with dressings continued until complete wound healing is achieved. Based on the study hypothesis, amniotic membrane dressings are expected to provide a clinically superior alternative to Aquacel® Ag dressings in the management of second-degree burns, particularly with respect to healing time and participant comfort.

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

盲法说明

analyst only

入排标准

性别
All
接受健康志愿者

入选标准

  • second degree burns (till 40% TBSA)
  • In patients/ OPD
  • Fire Burn, Scald Burn, Flash Burn.

排除标准

  • Referred Cases, Infected Wounds, Diabetic Patients/ on immunosuppressants/ corticosteroids,
  • Electrical & Chemical Burns/

研究组 & 干预措施

Amniotic membrane dressing group

Experimental

application of preserved amniotic membrane dressing on second degree burns until healed

干预措施: preserved amniotic membrane dressing (Biological)

Aqua cel (Ag) dressing group

Active Comparator

application of aqua cel dressing on second degree burns until healed

干预措施: preserved amniotic membrane dressing (Biological)

结局指标

主要结局

Healing

时间窗: 21days

comparison of healing time between aqua cel and amniotic membrane dressing

次要结局

未报告次要终点

研究者

发起方
Patel Hospital, Pakistan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shazra Khalid

Resident Plastic Surgery

Patel Hospital, Pakistan

研究点 (1)

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