The Effects of Prophylactic Limited Palmar Fasciectomy on Surgical Outcomes and Scarring
Primary Purpose
Dupuytren Contracture
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pretendinous cord excision
Division/manipulation of the cord
Sponsored by
About this trial
This is an interventional treatment trial for Dupuytren Contracture
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- <18 years of age
Sites / Locations
- Mayo ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pretendinous cord excision
Division/manipulation of the cord
Arm Description
Patients will undergo either a targeted palmar fasciectomy procedure in which the involved Dupuytren's fascia will be excised
patients will undergo either a targeted palmar fasciectomy procedure in which the involved Dupuytren's fascia will be incised.
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03155854
Brief Title
The Effects of Prophylactic Limited Palmar Fasciectomy on Surgical Outcomes and Scarring
Official Title
The Effects of Prophylactic Limited Palmar Fasciectomy on Surgical Outcomes and Scarring for Dupuytren's Contracture Patients With Pretendinous Cord - Prospective Randomized Clinical Study (Pilot)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
Patients who have surgery for trigger finger with a thickened overlying Dupuytren's cord are at risk for complications including but not limited to scarring, adhesions, stiffness, injury to underlying structures such as blood vessels, tendons and nerves, loss of motion, pain, bowstringing, and recurrent triggering or contracture. They have been shown to have higher risk for these complications including a thickened scar response. The cause for this is not fully understood, but it could be because the pretendinous cord was cut and not removed. By cutting and not removing this pretendinous cord, this may cause extra scarring that may lead to a thicker palmar scar that may become symptomatic. This study will investigate a different surgical method for relieving the tension caused by a pretendinous cord and whether it reduces complications and scarring.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dupuytren Contracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pretendinous cord excision
Arm Type
Active Comparator
Arm Description
Patients will undergo either a targeted palmar fasciectomy procedure in which the involved Dupuytren's fascia will be excised
Arm Title
Division/manipulation of the cord
Arm Type
Active Comparator
Arm Description
patients will undergo either a targeted palmar fasciectomy procedure in which the involved Dupuytren's fascia will be incised.
Intervention Type
Procedure
Intervention Name(s)
Pretendinous cord excision
Intervention Description
The cord/palmar fascia will be excised during surgery.
Intervention Type
Procedure
Intervention Name(s)
Division/manipulation of the cord
Intervention Description
The pretendinous cord will be divided and incised during surgery.
Primary Outcome Measure Information:
Title
Change in Scar Progression as measured by the Vancouver Scar Scale
Description
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 year
Title
Change in Scar Progression as measured by the Patient and Observer Scar Assessment Scale
Description
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 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
<18 years of age
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sanjeev Kakar, MD
Email
Kakar.Sanjeev@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjeev Kakar, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
The Effects of Prophylactic Limited Palmar Fasciectomy on Surgical Outcomes and Scarring
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