Can the Number of Skin Tears be Reduced, by Prophylactic Treatment of the Skin in Dupuytrens Contracture Treated With Collagenase?
- Conditions
- Dupuytren Disease of Finger
- Registration Number
- NCT07133945
- Lead Sponsor
- Zealand University Hospital
- Brief Summary
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.
- Detailed Description
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.
1. Standard treatment regime
2. Standard treatment regime + vaseline on skin over the cord and the hand is wrapped in a plastic glove till next day
3. Standard treatment regime + Silicone patch on skin over the cord and the hand is wrapped in a plastic glove till next day
4. Standard treatment regime + Steristrips on skin over the cord and the hand is wrapped in a plastic glove till next day
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- Dupuytrens contracture
- Extension deficit of 30 degrees or more in the metacarpophangeal joint or the proximal interphalangeal joint
- Previous treatment of the digit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Tear of skin 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Zealand University Hospital
🇩🇰Køge, Zealand, Denmark
Zealand University Hospital🇩🇰Køge, Zealand, Denmark