The Effects of Prophylactic Limited Palmar Fasciectomy on Surgical Outcomes and Scarring
ConditionDupuytren Contracture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
Research is instrumental for improving medical care and the patient experience. Finding new surgical techniques can create better outcomes and minimize recovery time and complications for patients. Some patients undergoing trigger finger surgery with a pre-existing Dupuytren's cord may develop a thickened surgical scar after surgery, which can cause discomfort, difficulty with moving or using, and other complications in the affected finger(s) or hand. The investigator is investigating a surgical technique to minimize these potential complications and scarring after surgery.
Subjects are being asked to take part in this research study because they have been diagnosed with trigger finger and pretendinous Dupuytren's cord and have decided to undergo surgery rather than try medical treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Potential candidates for the study will be selected based upon clinical diagnosis of trigger finger with co-existing pretendinous cord. All potential subjects will have either failed non operative treatment or elected surgical treatment.
Disqualifiers
<18 years of age
Trial design
Design model
Parallel
Treatments tested in this trial
Pretendinous cord excision
Procedure/SurgeryThe cord/palmar fascia will be excised during surgery.
Division/manipulation of the cord
Procedure/SurgeryThe pretendinous cord will be divided and incised during surgery.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Pretendinous cord excisionActive comparator 1 intervention
Group B: Division/manipulation of the cordActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Scar Progression as measured by the Vancouver Scar Scale
The Vancouver Scar Scale assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation. Patient perception of his or her respective scars is not factored in to the overall score. The scores can range from 0 (normal) to 13 (severe scarring).
Time frame
baseline, up to 1 year2
Change in Scar Progression as measured by the Patient and Observer Scar Assessment Scale
The Patient and Observer Scar Assessment Scale consists of two parts: a Patient Scale and an Observer Scale. Both scales contain seven items that are scored numerically on a 10-step scale. Together they make up the 'Total Score' of the Patient and Observer Scale. The total score can range from 14 (normal) to 140 (worst scar imaginable).
Time frame
baseline, up to 1 yearSponsors and contacts
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Source ClinicalTrials.gov