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临床试验/NCT07149844
NCT07149844已完成1 期

Comparing the Effects of Tea Tree Oil (Melaleuca Alternifolia) and Conventional Topical Dressing on Healing of Second-Degree Burn Wounds

Alexandria University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年7月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
30
试验地点
1
主要终点
morphological wound changes

研究概览

简要总结

Tea tree oil (TTO) has been recognized for its effectiveness in treating infected burns, insect bites, and promoting wound healing. This clinical study aimed to compare the impact of Tea tree oil dressings versus conventional ones in the healing process of second degree burns wounds.

详细描述

This quasi-experimental comparative controlled clinical trial was conducted at the Burn Unit of Ras-Elteen General Hospital in Alexandria, Egypt. A purposive sample of 30 adult patients with second-degree burns on the chest, abdomen, upper limbs (excluding hands), and lower limbs (excluding feet) was enrolled from the Emergency and Outpatient Departments. Participants were sequentially assigned to two equal groups:

Control group (n=15): Received conventional dressings (sterile gauze with silver sulfadiazine).

Study group (n=15): Received topical 10% tea tree oil (TTO) ointment applied directly to wounds.Wounds were cleansed with sterile normal saline (0.9%), and non-viable tissue was debrided.

Dressings were changed every other day unless soiled or damp. Burns near joints were maintained in functional positions.Wound assessment was performed on days 7, 14, and 21 post-treatment

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Patient willing to participate and communicate
  • Newly admitted with recent 2nd-degree burns (superficial or deep) involving ≤10% of TBSA
  • Length of hospital stay of 10 days

排除标准

  • Any associated illnesses that may affect wound healing, such as:
  • Diabetes mellitus (DM)
  • Immune disorders
  • Pre-existing skin conditions (e.g., eczema)

研究组 & 干预措施

conventional dressing

Other

Conventional dressing: Is the routine study hospital's burn dressing technique, utilizing sterile topical gauze dressing that is impregnated with or laid over a topical antibacterial, silver sulphadiazin dressing secured with adhesive tape.

干预措施: tea tree oil ointment (Drug)

结局指标

主要结局

morphological wound changes

时间窗: 3 weeks

assessment of: wound bed, wound margin: color, size, depth, presence of exudates: its amount, color, odor, and type, or scare, edema and granulation tissue formation; in addition to assessment of the wound's surrounding skin condition for: erythema, hotness, tenderness, swelling, separation of deep tissues, fever and peri-wound skin laceration. Each item was rated to score on 2 points Likert scale: 0 = not present and 1= Present. A total score of every patient in both groups was summed up and converted into percent score. to desribe wound healing process as ; complete healing: ; Partial healing: and No healing: where higher percent represent better healing

Local infection scoring system

时间窗: 3 weeks

Local infection scoring system was recorded as: 0= Absence of infection. 1= Presence of local signs of wound infection (redness, hotness, tenderness, purulent discharge and swelling)2 = Presence of systemic wound infection signs (fever, elevated WBCs, ESR and elevated CRP)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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