A prospective, non-controlled evaluation of the synthetic NovoSorb TM Biodegradable Temporising Matrix (BTM) for dermal repair after deep burn injury
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
The current treatment for patients with burns includes removing injured tissue and then covering the wound with a skin graft as soon as possible. If the burns are very large, there may not be enough skin available, so another treatment is needed. The aim of this study was to assess the safety and performance of a new medical device, NovoSorb BTM, for treating such patients. NovoSorb BTM is an implantable synthetic polyurethane layer that covers wounds and enables reconstruction of the deep skin layer. A total of 30 patients were recruited and had NovoSorb BTM applied to their burns. Of these, 26 patients were assessed, aged 18 to 70 years, 22 were male, they suffered burns to an average of 47.5% of their skin, and 22 patients completed the study. The results showed NovoSorb BTM was effective in providing temporary wound coverage to the burns. NovoSorb BTM also provided good support for the skin grafts applied to the wounds, enabling the wounds to heal quickly and the scars to improve over time. No new risks were identified. The results of this study provide additional evidence to support the continued use of NovoSorb BTM for treating patients with severe burns. Limitations of this study included the relatively small number of patients and not all patients completed the study. Patients were assessed for up to 12 months after their burn injury. In some patients, their scars were still changing and improving, so continuing to follow patients for a longer time is recommended.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. Patients suffering thermal burn injuries (deep-dermal/full thickness) involving 10-70% total body surface area (TBSA) requiring excision and split skin grafting.
- •2. Patients aged 18 - 70 years, inclusive.
- •3. Patient agrees to all required follow-up procedures and visits.
- •4. Patient or legal representative provides written, informed consent.
排除标准
- •1. Patient with burn(s) solely confined to the following excluded” anatomical sites: hands, face, neck and soles of the feet.
- •2. Females who are pregnant or breast-feeding, or who may get pregnant during the period of the study or who are of childbearing potential and unwilling to use a reliable method of contraception
- •3. Patient with history of allergy or previous reaction to polyurethane dressing materials.
- •4. Patient with a concomitant medical condition with a life expectancy of less than 12 months (e.g. advanced malignancy).
- •5. Patient who has a pre-existing infection which may interfere with the take of the matrix.
- •6. Patient who has expressed a refusal to participate.
- •7. Patients who are participating in another clinical trial which has the potential to affect the outcome of this study.