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Completed

NCT Number: NCT07133945

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

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.

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Key information

Conditions

Dupuytren Disease of Finger

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zealand University Hospital

Køge, Region Sjælland, 4600, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silicone plaster or Steristrip or Vaseline

Procedure

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

Primary outcomes

  1. Tear of skin

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2025
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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