Effectiveness Comparison Between the Use of Skin Micro-grafts vs Meshed Split Thickness Skin Grafts in Cutaneous Defects: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage of epithelialization
研究概览
简要总结
This is a double-blind randomized controlled clinical trial, that compares the percentage of epithelialization of skin defects using the conventional meshed split thickness skin grafts vs skin micro grafts.
Two techniques will be applied in the same patient. The skin defect will be divided in two parts, and with a randomized method each half of this defect will be assigned to one of the two techniques.
详细描述
Split thickness skin graft is the standard technique in skin defects reconstruction.
The etiology of this problem is diverse (burns, infections, trauma, cancer) however, many times the availability of donor areas are insufficient and morbidity and complications that may arise make prohibitive the use of this technique in many situations.
Skin micro grafts technique consists in using a very small part of skin (0.8x 0.8 mm) and keratinocyte growth-factor solution that allows a 1:50- 1:100 skin expansion. It has many advantages: it can be performed with local anesthesia and donor area is tiny.
The study consists in using the conventional and the new technique in the same patient. The skin defect will be divided in two parts, and with a randomized method each half of this defect will be assigned to one of the two different techniques. The result variable will be the "percentage of epithelialization" and will be compared in the two halves. This variable will be measured at day 14 using clinical and image software methods. The patient and the investigator that record the outcome variable will be blinded to the type of technique.
The investigators will take skin biopsies of two halves and will perform pathology studies.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non complicated wounds (no infection, no cancer)
- •Wound area: 20 x 20 cms or less
- •Located in diverse anatomical regions (except axillar, groin, genital, sole, scalp and flexion or extension areas)
排除标准
- •High cardiovascular risk
- •Patients with indication of a different technique
研究组 & 干预措施
Standard skin graft
This group is comprised of patients' wound halves that will receive meshed (1:3) split thickness skin graft (0.3-0.5mm thickness). This half will be covered with a standard "tie over" dressing. The dressing will be removed at day 5, and then it will be removed every 3 days up to the 14th day.
干预措施: Standard skin graft (Procedure)
Skin micro graft
This group is comprised of the patients' wound halves that will receive skin micro grafts. To obtain this grafts the investigators will use "Xpansion micro-autografting" system. They will use 0.8 x 0.8 mm skin grafts with a graft to graft distance of 4mm (1:50 expansion).This half will be covered with a special hydrogel dressing with keratinocyte growth factor (Epilife medium with calcium) 1.5ml for each 14 square centimeters of the wound. This half will be covered with a wet adhesive foam dressing and then it will be covered up with a non-adherent interface dressing (tegaderm). The dressing will be removed at day 5, and then it will be removed every 3 days up to the 14th day. Each time of dressing change only the non-adherent interface dressing will be removed, and the area will be bathed with keratinocyte growth factor solution.
干预措施: Skin micro Grafts (Procedure)
结局指标
主要结局
Percentage of epithelialization
时间窗: 14th day
It will be measured with imaging software (comparing color density) in order to calculate the percentage of epithelialization at day 14 compared with the initial wound area
次要结局
- Clinical percentage of epithelialization(14th day)
- Histological study(14th day)
研究者
Alejandro Cruz Segura
MD
Coordinación de Investigación en Salud, Mexico