Randomized-controlled Trial of Wound Healing, Pain, Microbiology, Handling and Thrift of Different Wound Dressings in Patients With Split-skin Grafted Third Degree Burns
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Epithelialization
研究概览
简要总结
In plastic and reconstructive surgery, treatment strategies of second-degree burn wounds and split-skin grafted third-degree burn wounds aim at reducing infection and improving reepithelialization. Although previous studies indicate that burn patients benefit from newer wound dressings, only a few studies comparing different wound dressings can be found. Therefore, the aim of this study is to evaluate time to reepithelialization, pain, microbiology, handling and costs of different wound dressings in patients with split-skin grafted third-degree burn wounds.
详细描述
In the treatment of burn wounds polyhexanide and betaisodona (PVP-Iod) are regularly used today. They act as antiseptics, but both have drawbacks. Polyhexanide evaporates fast and therefore cools patients when applied to a large wound area. Moreover, it is known to reveal a gap for pseudomonas. On the other hand, the half-life of Betaisodona (PVP-Iod) ranges between several minutes and 12 hours. Further, its application causes intense pain, and it is cytotoxic. Other wound dressings involving silver are frequently used, too. However, they color the wounds, which might therefore not be properly assessed. Silver is also thought to be cytotoxic.
New innovations are available today. In wound dressings with bound Silver ions wounds are not colored. Hydrolytic membranes keep the level of acidity low (acidic) and have therefore antiseptic effects that last until epithelialization of a second-degree burn wounds is completed. Medical honey is used in the treatment of chronic wounds and especially in pediatric surgery and oncology. Manuka honey from New Zealand is sterilized before application and is known to be less painful for the patient. Due to its acidic effect, it reduces germ numbers in the wounds. Honey can be left on the wound for more than one day, as well as hydrogel, that is also used for contaminated wounds.
These new wound dressings are just used in a couple of Burn Units for the treatment of second-degree burns or split-skin grafted burns. However, the treatment of large burn wounds with older dressing regimes (e.g. PVP-Iod) cause intensive pain in every dressing change.
Only a few studies pointing at new dressings in burn wounds can be found in the literature. None of them reveals a high quality randomized trial.
The objective of this clinical investigation is a direct comparison of established and newer wound dressings with respect to epithelialization time, pain and the number of pathogenic microbe species. Besides, handling and cost are analyzed.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent-capable male and female patients
- •≥18 years of age
- •≥3% and ≤30% total body surface area (TBSA) split-skin grafted third-degree burn
- •appropriate form of wound (not: too small) and localization (not: face, inplane surface)
- •ability to asses pain
排除标准
- •Immunosuppressive Therapy
- •Clinical wound infection
- •Allergy against porcine material, bee poison or honey, etherial oil, propyleneglycol, silver, nylon
- •Relationship to someone who is involved in the study design or assessment
- •Participation in other clinical trials
- •Citizen of countries outside Europe
结局指标
主要结局
Epithelialization
时间窗: through study completion, an average of 1 year
Percent of epithelialized area
次要结局
- Pain (on a visual analogue scale 0-10)(through study completion, an average of 1 year)
- Microbiologic Smear(through study completion, an average of 1 year)
- Subjective Handling(through study completion, an average of 1 year)
研究者
Tobias Kisch
Principal Investigator
University Hospital Schleswig-Holstein