The Effects of Prophylactic Limited Palmar Fasciectomy on Surgical Outcomes and Scarring

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03155854
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mayo Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sanjeev Kakar, MD
Principal Investigator Affiliation	Mayo Clinic
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Dupuytren Contracture
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Pretendinous cord excision

Patients will undergo either a targeted palmar fasciectomy procedure in which the involved Dupuytren's fascia will be excised

Active Comparator: Division/manipulation of the cord

patients will undergo either a targeted palmar fasciectomy procedure in which the involved Dupuytren's fascia will be incised.

Interventions

Procedure: - Pretendinous cord excision

The cord/palmar fascia will be excised during surgery.

Procedure: - Division/manipulation of the cord

The pretendinous cord will be divided and incised during surgery.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Site Contact

[email protected]

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