跳至主要内容
临床试验/NCT02083900
NCT02083900Unknown2 期

Use of Banana Leaf Dressing on Donor Site Wounds: A Prospective Randomized Control Study

University of the Philippines1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2006年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
10
试验地点
1
主要终点
Healing Assessment and Efficacy of the dressing

研究概览

简要总结

Prospective Randomized double-blind controlled trial comparing the healing rate, infection rate, pain score, ease of care and scar formation of Banana leaf dressing versus hydrocolloid dressing.

详细描述

Prospective Randomized double-blind controlled trial comparing the healing rate, infection rate, pain score, ease of care and scar formation of Banana leaf dressing versus hydrocolloid dressing.

Adult patients with no uncontrolled medical condition admitted at Philippine General Hospital Burn Center requiring split thickness skin graft for their burn. this is to compare the efficacy and safety of Banana Leaf Dressing with Hydrocolloid dressing among patients undergoing split thickness skin graft for their burn.

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
Double (Participant, Care Provider)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient undergoing harvesting of skin graft one or both thigh
  • Surgery under general anesthesia
  • Given informed consent and has accomplished a written inform consent

排除标准

  • Patient with uncontrolled medical condition such as diabetes or hypertension
  • Pregnant females
  • Patients in whom legs or back was used as donor site
  • Surgery under regional anesthesia
  • Refused inclusion into the study
  • Patients who had previous skin harvesting on the area of the study

研究组 & 干预措施

Banana Leaf Dressing Group

Experimental

The Banana Leaf Dressing site will receive a single layer of banana leaf dressing

干预措施: Banana Leaf Dressing (Device)

Hydrocolloid Dressing Arm

Active Comparator

The donor under Hydrocolloid dressing was covered with hydrocolloid (DuoDERM CGF).

干预措施: Hydrocolloid Dressing (DuoDERM CGF) (Drug)

结局指标

主要结局

Healing Assessment and Efficacy of the dressing

时间窗: 8th post harvest day

After 8th post harvest day The degree of healing will be assessed. Direct inspection of the wound will be made by experienced burn surgeon. The degree of re-epithelialization will be graded as follow: No Re-epithelialization = zero (0); Less than 50% = one (1); More than 50% but not complete = Two (2), and Complete (90% or more) = Three (3). Complete Re-epithelialization is synonymous to healing on which 90% or more of the wound surface is re-epithelialized.

次要结局

  • Pain Scores(taken from 24hours, on the 48th and 72 hour post skin harvest)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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