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

NCT07133945 | Completed DMC

• 1 other identifier: REG-185-2017
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Dupuytren Disease of Finger

Keywords

Collagenase; Xiapex; Vaseline; Steristrip; Silicone

Outcome Measures

Primary Outcomes (1)

• Tear of skin

  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.

  During breaking af dupuytren cord following collagenase treatment. Time frame is thus within approximately 10 seconds

Study Arms (2)

Control group

NO INTERVENTION

This group will receive standard collagenase injection in the cord

Experimental group

EXPERIMENTAL

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

Procedure: Silicone plaster or Steristrip or Vaseline

Interventions

Silicone plaster or Steristrip or Vaseline PROCEDURE

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous treatment of the digit

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital

Køge, Region Sjælland, 4600, Denmark

Location

MeSH Terms

Interventions

Petrolatum

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: August 21, 2025
• Study Start: January 1, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: August 21, 2025

Record last verified: 2018-12

Locations

DK (1)