Pediatric Burn Treatment Using Tilapia Skin as a Xenograft for Superficial-Partial Thickness Wounds: a Randomized Controlled Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment of pain via the Faces Pain Scale-Revised (FPS-R).
研究概览
简要总结
This study aims to evaluate the efficacy of Nile tilapia skin as a xenograft for the treatment of partial-thickness burn wounds in children.
详细描述
This is an open-label, monocentric, randomized phase II pilot study conducted in Fortaleza, Brazil. The study population consisted of 30 children between the ages of 2 and 12 years with superficial "partial-thickness" burns admitted less than 72 hours from the thermal injury. In the test group, the tilapia skin was applied. In the control group, a thin layer of silver sulfadiazine cream 1% was applied.
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
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between the ages of 2 and 12 years admitted to our institution with superficial partial thickness burns less than 72 hours from the thermal injury
排除标准
- •Patients were excluded for a burn greater than 15% total body surface area (TBSA);
- •Presence of a previous treatment for the current burn;
- •Presence of a chemical or electrical burn;
- •Presence of other significant diseases that could impact the volunteer's participation in the study;
- •Presence of hypersensitivity to materials used in the study or to related compounds.
研究组 & 干预措施
Test - Tilapia Skin
After cleaning the lesion with tap water and 2% chlorhexidine gluconate, the tilapia skin was applied and covered with gauze and bandage.
干预措施: Tilapia skin (Other)
Control - Silver sulfadiazine
After cleaning the lesion with tap water and 2% chlorhexidine gluconate, a thin layer of silver sulfadiazine cream 1% was applied and covered with gauze and band
干预措施: silver sulfadiazine cream 1% (Drug)
结局指标
主要结局
Assessment of pain via the Faces Pain Scale-Revised (FPS-R).
时间窗: Day 11
The pain evaluation via the FPS-R was performed by the patient himself or herself if aged 5 years or more, or by their caregiver in patients under 5 years of age. The scale consists of six faces, presented horizontally, that depict different degrees of pain, from "no pain" to "most pain possible". A numerical value from 0 to 10 is assigned to each face.
Assessment of pain via FLACCr scale.
时间窗: Day 11
The pain evaluation via FLACCr scale was performed by the physician responsible and answered five evaluation categories based on behavioral parameters with combined scores ranging from zero to ten (classified the scores as follows: zero to three (mild pain); four to six (moderate pain) and seven to ten (severe pain).
Complete burn wound healing
时间窗: Day 11
The number of days to complete burn wound healing (≥95% reepithelialization), calculated via clinical judgment from the consultant.
Assessment of pain via CONFORT-B scale.
时间窗: Day 11
The pain evaluation via CONFORT-B Scale was performed by the physician responsible and assessed the pain based in a behavioral that consisted in six factors: alertness, calmness/agitation, respiratory response (or crying), physical movement, muscle tone, and facial tension.Each factor was scored with values ranging between 1 and 5, generating scores between 6 and 30 points.
次要结局
- Number of dressings performed.(Day 11)
- Total amount of anesthetics and analgesics required throughout the treatment(Day 11)
- Evaluation of burn improvement via the Clinical Global Impression Scale-Improvement (CGI-I).(Day 3, day 5, day 7, day 9 and day 11)
- Evaluation of burn severity via the Clinical Global Impression Scale- Severity (CGI-S).(Day 1, day 3, day 5, day 7, day 9 and day 11)
研究者
Edmar Maciel Lima Júnior
Plastic Surgeon
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara