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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07133945
Enrollment
34
Registered
2025-08-21
Start date
2018-01-01
Completion date
2018-06-30
Last updated
2025-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dupuytren Disease of Finger

Keywords

Collagenase, Xiapex, Vaseline, Steristrip, Silicone

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

Interventions

PROCEDURESilicone plaster or Steristrip or Vaseline

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

Sponsors

Zealand University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Tear of skinDuring breaking af dupuytren cord following collagenase treatment. Time frame is thus within approximately 10 secondsDoes 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026