A Prospective Multi-centre Randomised Study for Treatment of Burns With Dermis Graft or Split-thickness Skin Auto-graft.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Healing time
研究概览
简要总结
Study Synopsis
Title; The dermis graft: epithelialization and late scar evaluation A Clinical Prospective multicenter trial
Objectives; The objective of this study is to compare a dermal graft with a conventional split thickness skin graft regarding healing quality and scarring.
Design; the study is a prospective, controlled clinical multicenter trial.
Study population; Atleast 20 burn patients (18-80 years) with a full thickness burn that requires permanent skin cover.
Time plan; Enrollment will continue until atleast 20 patients have been included and completed the study.
详细描述
Background: Donor site morbidity is a major concern such as wound healing disturbances, hypertrophic scarring and hypo-/hyperpigmentation. The dermal graft technique is an alternative to the standard split-thickness skin graft (STSG) technique to minimize donor site morbidity. Immediate cover of the donor site after harvest leaving a non-exposed wound is a big advantage. The aim of the study was to compare the functional and aesthetic outcome between two treatment methods (dermal graft with STSG).
Methods: From February 2017 to December 2020, 21 patients received a dermis graft and a regular split-thickness skin graft in a prospective randomized study design. The recipient and the donor site were compared separately regarding healing time, scarring and patient subjective satisfaction. All sites (both donor and recipient) were analyzed histologically regarding remodeling and scar formation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Thermal & chemical burns < 30 % TBSA
- •Males & females between 18-80 years old
- •At least one coherent full thickness wound measuring 15 x 7.5 cm
- •A minimal of 15 x 7.5 cm coherent undamaged skin located at frontal or lateral side of one of the thighs for graft harvest.
排除标准
- •Patients with severe cutaneous trauma at the same site as the burn injury
- •Previous burns at the treatment site
- •Severe cognitive dysfunction or psychiatric disorder
- •Chronic skin disorder
- •Chronic use of systemic or local corticosteroid
- •Chronic use of anticoagulants or platelets
- •Autoimmune disease
- •Active hepatitis
- •Full thickness burns of head, genitalia, axilla or upper third of medial upper arm
结局指标
主要结局
Healing time
时间窗: 4 weeks
Recipient sites are to be assessed regarding healing (re-epithelization) at each site (donor respective recipient). Healing will be assesed in days after surgery.
Aesthetic outcome
时间窗: 12 months
The aesthetic appereance regarding scarring will be assessed. A MPA580 cutometer will asses the viscoelasticity in the skin and POSAS will asses the appereance of the scar objectively as subjectively. R0 and R2 will be used as variables evaluating firmness and elasticity. POSAS will be analysed accoring to a scoring system (0-10 and 0-60).
次要结局
未报告次要终点
研究者
Folke Sjoberg
Professor
University Hospital, Linkoeping