Evaluation of Nile Tilapia (Oreochromis Niloticus) Skin as an Occlusive Biological Dressing in the Treatment of Burn Wounds: Phase III Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Number of dressings performed
研究概览
简要总结
The present study is a Phase III Randomized Clinical Trial aiming to evaluate the efficacy of Nile tilapia (Oreochromis niloticus) skin as an occlusive biological dressing in the treatment of superficial partial-thickness burns in adults.
详细描述
This is a prospective, randomized, monocentric, open-label, controlled phase III clinical study conducted in Fortaleza, Brazil, from April 2017 to October 2018. The local Institutional Review Board approved the study protocol and informed consent, which was obtained from all participants. The research was conducted in accordance with the 1975 Declaration of Helsinki and its amendments.
The study population consisted of 115, both male and female, participants, who were recruited from a local burn treatment center. Inclusion criteria were: age ≥ 18 and ≤60 years; the presence of dermatological wounds caused by superficial partial-thickness burns (SPTB) affecting up to 15% of Total Body Surface Area (TBSA) and with indication for outpatient treatment; the absence of previous treatment for the current burn and an absence of other significant diseases that could impact the volunteer's participation in the study (coronary artery disease, peripheral vascular disease, cancer, diabetes mellitus, among others). Exclusion criteria included hypersensitivity to materials used in the study or to related compounds; history of severe adverse reactions; drug addiction, including alcohol; use of medications that could have an impact on wound healing (e.g., steroids) and pregnancy, labor or miscarriage in the 12 weeks before the scheduled start of treatment.
In the test group, the treatment was Nile Tilapia Fish Skin, which have a patent registered at the National Institute of Industrial Property (INPI) under number BR 10 2015 021435 9. Nile Tilapia Fish Skin was subjected to a rigorous process of chemical sterilization, glycerolization and irradiation, followed by microbiological tests for bacteria and fungi, before storage in sterile refrigerated packaging. Prior to its use in the patient, the skin was washed in sterile 0.9% saline for 5 minutes, with this process being repeated three times in a row. In the control group, conventional treatment with silver sulfadiazine cream 1% was applied. Randomization was performed using a predefined computer-generated list, with 57 patients being allocated in the test group and 58 patients being allocated in the control group.
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
Patients were blinded to the hypothesized effects of either treatment, but neither the patients nor the consultant were blinded to the treatment administered, due to the necessity of visualizing the treatments in order to conduct them properly (i.e., both types of dressing need to be seen to be applied, evaluated, replaced and removed adequately).
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤60 years.
- •Presence of dermatological wounds caused by superficial partial-thickness burns (SPTB) affecting up to 15% of Total Body Surface Area (TBSA).
- •Patient with indication for outpatient treatment.
排除标准
- •Previous treatment for the current burn.
- •Presence of other significant diseases that could impact the volunteer's participation in the study (coronary artery disease, peripheral vascular disease, cancer, diabetes mellitus, among others).
- •Hypersensitivity to materials used in the study or to related compounds.
- •History of severe adverse reactions; drug addiction, including alcohol.
- •Use of medications that could have an impact on wound healing (e.g., steroids).
- •Pregnancy, labor or miscarriage in the 12 weeks before the scheduled start of treatment.
研究组 & 干预措施
Silver Sulfadiazine Cream 1%
In the control group, 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 bandage. The dressing changes occurred every 48 hours. The patients were evaluated every 48 hours for the study parameters.
干预措施: Silver Sulfadiazine Cream 1% (Drug)
Nile Tilapia Fish Skin
In the test group, the treatment was Nile Tilapia Fish Skin, which have a patent registered at the National Institute of Industrial Property (INPI) under number BR 10 2015 021435 9. Nile Tilapia Fish Skin was subjected to a rigorous process of chemical sterilization, glycerolization and irradiation, followed by microbiological tests for bacteria and fungi, before storage in sterile refrigerated packaging. Prior to its use in the patient, the skin was washed thrice in sterile 0.9% saline for 5 minutes, in order to remove glycerol. Regarding application in the study patients, after cleaning the lesion with tap water and 2% chlorhexidine gluconate, Nile Tilapia Fish Skin was applied and covered with gauze and bandage. Throughout the treatment, dressings with Nile Tilapia Fish Skin were only changed if the biomaterial was not properly adhered to the wound bed. The patients were evaluated every 48 hours for the study parameters.
干预措施: Nile Tilapia Fish Skin (Device)
结局指标
主要结局
Number of dressings performed
时间窗: Day 11
In the control group, a dressing change was defined as the act of cleaning the wound and reapplying the Silver Sulfadiazine Cream 1%, which was performed every 48 hours. In the test group, a dressing change was defined as the act of replacing the Nile Tilapia Fish Skin which did not adhere properly and/or replacing gauze and bandage that is full of exudate.
Amount of anesthetics used throughout the treatment
时间窗: Day 11
In order to audit analgesic intake, apart from the medication prescription (dipyrone and/or tramadol), the patients received a daily record card. They were asked to take the medication only if they felt pain, always respecting instructions in the prescription, and to register the amount of medication taken and the date on the card. Upon returning for medical evaluation, the remaining medication was checked and compared to the daily record card.
Number of days for complete reepithelialization of the burn wound
时间窗: Day 11
Number of days until complete reepithelialization of the burn wound, considering application of the first dressing as day zero. Complete reepithelialization was defined as a ≥95% reepithelialization calculated via clinical judgment from the consultant
Treatment cost per patient
时间窗: Day 11
Consumption of materials of the burn treatment center was controlled by the completion of a specific form, an activity performed at the end of each patient visit by the nursing staff. The resources consumed were divided into three categories: a) products used for wound management (either Nile Tilapia Fish Skin or Silver Sulfadiazine Cream 1%); (b) hospital material required for dressing preparation (such as sterile gloves, chlorhexidine, gauze, and bandage); and c) analgesic medication required throughout treatment (dipyrone and/or tramadol). Human resources were not evaluated.
次要结局
- Pain intensity evaluation via Visual Analogue Scale scores(Day 1, 3, 5, 7, 9 and 11)
- Burn improvement on the day of dressing removal evaluation(Day 11)
- Pain intensity evaluation via Electronic von Frey(Day 1, 3, 5, 7, 9 and 11)
- Burns Specific Pain Anxiety Scale (BSPAS) scores(Day 5 and 11)
研究者
Edmar Maciel Lima Júnior
MD, Plastic Surgeon
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara