Can the Number of Skin Tears be Reduced, by Prophylactic Treatment of the Skin in Dupuytrens Contracture Treated With Collagenase?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Tear of skin
研究概览
简要总结
Collagenase has gained pace in treating Dupuytrens contracture for some years. Thus this treatment is performed routinely in many orthopaedic and or hand surgical department. One of these benefits of the collagenase treatment is that the patients quickly recover and return to work or daily activities after the treatment. However, one of the often seen complications to the treatment is skin tear. This is reported in 20-80% of cases depending on the degree of contracture. The presence of skin tear leads to prolonged recovery, increased pain, scarring and post pone patients returning to daily activities and work. The investigators hypothesize that prophylactic initiatives with pre-existing products could reduce skin tear after treatment with collagenase injection into the Dupuytren cord.
详细描述
To the knowledge of the investigators no effective measures exists for preventing skin breakage following collagenase treatment of Dupuytrens disease. In the current study three different skin treatments are tested against a control group to see if skin breakage can be reduced by one of these prophylactic measures.
The study is performed as a prospective randomized non blinded study.
The degree of contraction is measured. Injection of collagenase into the cord. According to randomization the patient will be allocated to one of the following four treatments.
- Standard treatment regime
- Standard treatment regime + vaseline on skin over the cord and the hand is wrapped in a plastic glove till next day
- Standard treatment regime + Silicone patch on skin over the cord and the hand is wrapped in a plastic glove till next day
- Standard treatment regime + Steristrips on skin over the cord and the hand is wrapped in a plastic glove till next day
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dupuytrens contracture
- •Extension deficit of 30 degrees or more in the metacarpophangeal joint or the proximal interphalangeal joint
排除标准
- •Previous treatment of the digit
研究组 & 干预措施
Control group
This group will receive standard collagenase injection in the cord
Experimental group
This group will receive vaseline treatment, silicone plaster or steristrip on the skin overlying the cord before breakage of the cord
干预措施: Silicone plaster or Steristrip or Vaseline (Procedure)
结局指标
主要结局
Tear of skin
时间窗: During breaking af dupuytren cord following collagenase treatment. Time frame is thus within approximately 10 seconds
Does the skin tear when breaking the dupuytren cord? yes or no. There is no recognized scale for this observation. Only the registration of the skin tearing or not.
次要结局
未报告次要终点