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''
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
- 否
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
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
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
Shazra Khalid
Resident Plastic Surgery
Patel Hospital, Pakistan
