Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Complete epithelialization of the wound
研究概览
简要总结
The evidence is insufficient to determine whether the types of dressings containing silver differ in time / proportion for complete wound healing and pain. We will analyze the cost-effectiveness of these dressings in outpatients, considering the service provided by the Brazilian National Public Health System.
详细描述
Randomized, single-center, single-blinded, controlled clinical trial. Adult patients (age between 18 and 65 years), regardless of sex, with second degree burns treated in outpatient regimen will be randomized (1:1) into two groups: 1% silver sulfadiazine and nanocrystalline silver.
Primary outcome:
- Proportion of lesions completely epithelialized within 15 days.
Secondary outcomes:
- Time in days for complete epithelialization of the burned areas;
- Number of dressing changes;
- Level of pain associated with the application and removal of the dressings;
- Direct medical and non-medical costs;
- Need for surgery;
- Incidence of infection;
- Presence of local adverse reactions.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 18 and 65 years;
- •Regardless of sex and ethnicity;
- •Presenting second degree burns (partial thickness involving the epidermis and part of the dermis, with at least the preservation of some dermal appendages from of which the wound can eventually be epithelialized spontaneously) (ARTZ; MONCRIEF; PRITT, 1980) under an outpatient regimen, without the need for surgical debridement of devitalized tissue and skin grafts informed in the initial clinical diagnosis.
排除标准
- •Patients with diabetes;
- •Pregnant women;
- •Patients with intellectual disabilities;
- •Patients with burns to the face or on the palmar face of the hands or on the plantar face of the feet, as the need for specific treatment was felt to prevent functional sequelae;
- •Patients who have already started treatment in other institutions;
- •Those whose burns had happened 5 or more days before their entrance in the hospital;
- •Those incapable of signing the informed consent form or who have declined to participate.
研究组 & 干预措施
Nanocrystalline silver
Flexible polyester low-grip coated nanocrystalline silver dressing. The dressing was applied to the lesion after being soaked in sterile distilled water. About this compresses to bandage movements will have been added and comes to avoid tourniquet bandage on-site maintenance, temperature of the affected area, cushioning and absorption of wound exudate when present. Is finished with the application of crepe bandages in the form of flakes containment curative and maintenance of pressure. This procedure aids in the bloodstream, and avoids the increased edema. The bandage is started from the periphery to the central region, avoiding tourniquet. The exchanges were performed every three days.
干预措施: Nanocrystalline silver (Drug)
Silver sulfadiazine
Ranges for rayon containing cream 1% silver sulfadiazine were used. Involving this layer, bandages for dressings were added in movements back and forth to avoid the tourniquet, providing maintenance of the temperature of the affected area, cushioning and absorption of wound exudate when present. This application was completed with crepe bandages to contain the dressing and maintain pressure. This procedure aids in the bloodstream, and avoids the increased edema. The bandage is started from the periphery to the central region, scales, avoiding the tourniquet. Dressing changes were performed daily.
干预措施: Silver Sulfadiazine (Drug)
结局指标
主要结局
Complete epithelialization of the wound
时间窗: 15 days
Proportion of lesions completely epithelialized during the specific time frame
次要结局
- Number of dressing changes(30 days)
- Sugery(90 days)
- Adverse reactions(90 days)
- Direct medical and non-medical costs of treatment(15 days)
- Infection(30 days)
- Level of pain(30 days)
研究者
Luciane Cruz Lopes
Professor - Researcher
University of Sorocaba