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

NCT ID: NCT07133945

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-06-30

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

Conditions

Dupuytren Disease of Finger

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

This group will receive standard collagenase injection in the cord

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental group

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

Group Type: EXPERIMENTAL

Silicone plaster or Steristrip or Vaseline

Intervention Type: PROCEDURE

Prophylatic treatment of the skin before breakage of the skin in dupuytrens disease

Interventions

Silicone plaster or Steristrip or Vaseline

Prophylatic treatment of the skin before breakage of the skin in dupuytrens disease

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zealand University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zealand University Hospital

Køge, Region Sjælland, Denmark

Countries

Denmark

Other Identifiers

REG-185-2017

Identifier Type: -

Identifier Source: org_study_id