Medico Economic Evaluation of Dermal Substitute Integra® for Coverage of Inferior Limb Traumatic Skin Loss
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 9
- 主要终点
- Auto-evaluation of patient's scar esthetical result with a visual analog scale.
研究概览
简要总结
Comparison of 2 techniques of surgery on patients with inferior limb traumatic wounds: the innovative technique Integra® and the technique of reference: the flap surgery.
详细描述
Traumatic skin loss with bone or tendon exposure essentially affects inferior limbs. There are considered serious as they often lead to functional and esthetical consequences, and they generally affect young people.
Flap surgery is the treatment of reference for these skin losses. This technique requires expensive material and a lot of medical staff. The intervention and duration of hospitalisation are often long with heavy medication. Post surgery complications or disabling sequelea involve surgical re-interventions which increase duration of hospital stay and medical staff availability.
The dermal substitute Integra® (Integra LifeSciences Corporation) is an advanced wound care device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan and a semi-permeable polysiloxane (silicone layer). This medical device allows formation of a neoderm. The silicon layer is a temporary layer which is removed when the neoderm is totally built. This surgery is fast, non-invasive, with short hospital stay and limited complications which can be treated easily.
Objective of the study: to assess medico-economic interest of innovative surgery using dermal substitute Integra® compared to the reference using flap surgery in the treatment of traumatic skin loss of inferior limbs. Assessment will be based on re-interventions incidence, long-term functional and esthetical scar results and total cost of each technique.
Study design: multicenter, randomized, open label, parallel design, clinical trial in 12 French plastic surgery / burn care centres.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with skin loss traumatic or chronic wound
- •wound located from mid third of the leg to distal extremity of feet
- •with muscle and/or tendon and/or bone and/or articulation exposure
- •requiring a first surgical intervention for the coverage of the skin loss
- •patient eligible to the Integra® surgery techniques
- •patient with social security affiliation
- •written informed consent signed by the patient or representative
排除标准
- •Bone fracture located in the skin loss
- •Non traumatic wound
- •Wound with muscle exposure only
- •Immunocompromised patient
- •Allergy to bovine collagen, glycosaminoglycans or silicon
- •patient with an healthstate that compromise the 18 months Follow-up
- •pregnant women / who intend to become pregnant within the 18 months of follow-up
- •Patient under administrative or legal supervision
研究组 & 干预措施
Flap technique
干预措施: Flap technique (Procedure)
INTEGRA®
干预措施: INTEGRA® (Device)
结局指标
主要结局
Auto-evaluation of patient's scar esthetical result with a visual analog scale.
时间窗: at 18 month-follow up
Occurrence of at least one complication requiring a surgical re-intervention
时间窗: Within the first 18 months after surgery
Persistence of an important / major trouble of the scar measured by a "scar-trouble scale" filled in by the patient.
时间窗: at 18 month-follow up
次要结局
- Occurrence of all post surgical complications(Within the first 18 months after surgery)
- Ïntensity of scar pain during cares evaluated with a visual analog scale and quality of life (EuroQol)(Within the first 18 months after surgery)
- Human and medical requirements(Within the first 18 months after surgery)
- Duration of hospitalization and healing(Within the first 18 months after surgery)
- Period until return to work and re-start of daily activities(Within the first 18 months after surgery)