跳至主要内容
临床试验/CTRI/2025/03/083539
CTRI/2025/03/083539尚未招募4 期

Effectiveness of banana leaf dressing versus paraffin tulle gras dressing in the management of pemphigus vulgaris wounds: A pilot within-person randomized controlled, blinded outcome assessment trial.

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年4月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
1.To assess the effectiveness of banana leaf dressings in comparison to paraffin tulle gras dressing on the wound healing as assessed by Bates-Jensen Wound Assessment Tool (BWAT) and Qualitative wound score (QWS) in patients with pemphigus vulgaris

研究概览

简要总结

Pemphigus vulgaris is an autoimmune blistering disorder characterized by widespread blisters and painful moist erosions involving large body surface area causing significant discomfort and distress to the patients. These erosions also predispose to development of infections and worsens the disease activity. Hence local wound care with the appropriate dressings is an essential component in the management of pemphigus patients apart from immunosuppressive therapy.  Banana leaves are an unlimited source of biomaterial and have a smooth and waxy surface that does not stick and has inherent wound healing properties as reported in various studies on burns, skin donor site wounds and facial traumatic wounds, making it a viable option in wound management resource poor settings.While there are published trials proving the therapeutic benefits of banana leaf dressing in burns patients, donor sites of split thickness grafts and contused, lacerated and sutured wounds of head and neck area, there are no studies that have evaluated effectiveness of banana leaf dressing in the management of wounds in pemphigus vulgaris except for a single case report.

If banana leaf dressing is found to be effective in achieving adequate wound healing and alleviation of symptoms in pemphigus vulgaris when compared to the conventional paraffin tulle gras dressing, it can be incorporated in the routine management of pemphigus vulgaris which can reduce the need for high expenditure on dressing, especially in tropical countries where banana leaves are available in abundance.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • 1.Consenting adult patients aged ≥ 18 years with active pemphigus vulgaris admitted in the der-matology wards 2.Patients with skin erosions involving ≥ 10% and ≤ 80% of the body surface area (BSA).

排除标准

  • 1.Patients with confluent erosions wherein dress-ings cannot be applied without carry-across ef-fect.
  • 2.Patients in sepsis.

结局指标

主要结局

1.To assess the effectiveness of banana leaf dressings in comparison to paraffin tulle gras dressing on the wound healing as assessed by Bates-Jensen Wound Assessment Tool (BWAT) and Qualitative wound score (QWS) in patients with pemphigus vulgaris

时间窗: Baseline, daily assessment

2.To compare the time taken for achieving complete reepithelization between the two groups

时间窗: Baseline, daily assessment

次要结局

  • 1.To compare the wound healing as assessed based on infrared thermography between the two groups(2.To compare the pain associated with wound and pain associated with dressing change between the two groups)

研究者

发起方
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Win Subash Babu

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry

研究点 (1)

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