Influencing Wound Healing Through the Application of Hyaluronic Acid With Perfluorodecalin and Physalis Angulata Extract After Split Skin Removal From the Thigh - A Study in "Split Wound Design"
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Effect of Ready Medical Post Treatment on wound healing after split skin removal
研究概览
简要总结
The study will use a split wound design to investigate whether secondary wound healing can be accelerated and improved by the application of hyaluronic acid combined with perfluorodecalin and Physalis angulata extract.
详细描述
In oral and maxillofacial surgery, split skin is regularly removed to cover secondary defects. These defects occur, for example, in tumor patients after the removal of microsurgical radialis or fibular grafts for defect coverage or reconstruction, since the skin cannot be primarily closed there.
Split skin is defined as a free skin graft made of epidermis and the upper parts of the dermis. The average thickness of the grafts is 0.2-0.8 mm. The thickness of the split skin determines the pigmentation structure and the quality of the graft. The thinner the split skin, the better the healing tendency and the less scar remains at the donor site. However, a disadvantage of thin split skin grafts is the stronger secondary shrinkage in the recipient region. Moderately thick grafts are hardly subject to scar shrinkage, but occasionally leave hypertrophic scars or keloids at the donor site. Split skin grafts with a thickness of 0.6-0.8 mm provide the best esthetic results, but have a poorer healing rate.
The split skin can be removed with a dermatome. The ventrolateral proximal thighs and the inside and outside of the upper arms are particularly suitable as donor regions.
In oral and maxillofacial surgery, a 0.4 mm thick split skin is usually removed from the ventrolateral thigh to cover the defect in the forearm or lower leg.
The requirement at the split skin removal site is rapid healing with complete re-epithelialization. To achieve this, wound management is currently left to the clinic itself, as there is no evidence-based standard care. The technical literature only recommends moist wound management and rare dressing changes.
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, Care Provider, Investigator)
盲法说明
The images taken from the wound as a progress control during the study should be evaluated anonymously by both the surgeon and the patient using the "Manchester Scar Scale" and the "Patient and Observer Scar Assessment Scale".
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-90 years
- •Split skin removal at the thigh must be planned for the patients
- •Adult patients who are mentally and physically able to understand the importance and scope of the study and to follow up the study staff
- •Written informed consent before participating in the study
排除标准
- •Patients suffering from a systemic disease (e.g. diabetes mellitus, anticoagulant therapy,...)
- •Patients taking immunosuppressive drugs that may affect wound healing
- •Patients suffering from skin diseases
- •Pregnant and/or lactating women. Women of childbearing age should protect themselves from potential pregnancy by adequate contraception while participating in studies.
- •Participation in a study may, at the investigator's discretion, present an unacceptable risk due to pre- or concomitant disease or the patient's general underlying condition.
- •Underage, or older than 90 years
- •Life span is less than six months
- •There is a current or past medically relevant disease or treatment that could influence the evaluation of the study
- •The patient has received a study medication within the last 30 days as part of another study
- •Simultaneous participation in another clinical intervention study
- •Expected lack of compliance
- •Alcohol or drug abuse
- •The patient is accommodated in an institution by official or court order
- •Patients in a dependent relationship or employment relationship with the sponsor, investigator, or alternate investigator
研究组 & 干预措施
Conventionell Treatment
After split skin removal, the wound is divided into 2 parts (=2 arms):
1st half: conventional treatment with moist dressings (mepilex and fixomull)
干预措施: Conventionell Treatment (Device)
Treatment with Ready Medical Post Treatment
After split skin removal, the wound is divided into 2 parts (=2 arms):
2nd half: conventional treatment with moist dressings (mepilex and fixomull) and additional treatment with ready medical post treatment
干预措施: Ready Medical Post Treatment (Drug)
结局指标
主要结局
Effect of Ready Medical Post Treatment on wound healing after split skin removal
时间窗: 6.5 month
Evaluation of the process control of wound healing (three-dimensional scans of the thigh) by surgeons and patients using questionnaire (wound assessment by "Manchester Scar Scale") Manchester Scar Scale: VAS (Visual Analog Scale) plus scar color, skin texture, relationship to surrounding skin, texture, margins, size, multiplicity (Score from 5 (best) to 18 (worse)
次要结局
未报告次要终点