Can the Number of Skin Tears be Reduced, by Prophylactic Treatment of the Skin in Dupuytrens Contracture Treated With Collagenase?

Zealand University Hospital

Status: Completed

Conditions: Dupuytren Disease of Finger

Treatments: Procedure: Silicone plaster or Steristrip or Vaseline

Study type: Interventional

Funder types: Other

Identifiers

NCT07133945

REG-185-2017

Details and patient eligibility

About

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.

Full 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

Enrollment: 34 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Dupuytrens contracture
• Extension deficit of 30 degrees or more in the metacarpophangeal joint or the proximal interphalangeal joint

Exclusion criteria

• Previous treatment of the digit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Control group

No Intervention group

Description:

This group will receive standard collagenase injection in the cord

Experimental group

Experimental group

Description:

This group will receive vaseline treatment, silicone plaster or steristrip on the skin overlying the cord before breakage of the cord

Treatment:

Procedure: Silicone plaster or Steristrip or Vaseline