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

NCT ID: NCT03155854

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Dupuytren Contracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pretendinous cord excision

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

Group Type ACTIVE_COMPARATOR

Pretendinous cord excision

Intervention Type PROCEDURE

The cord/palmar fascia will be excised during surgery.

Division/manipulation of the cord

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

Group Type ACTIVE_COMPARATOR

Division/manipulation of the cord

Intervention Type PROCEDURE

The pretendinous cord will be divided and incised during surgery.

Interventions

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Pretendinous cord excision

The cord/palmar fascia will be excised during surgery.

Intervention Type PROCEDURE

Division/manipulation of the cord

The pretendinous cord will be divided and incised during surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Sanjeev (Sanj) Kakar, M.D., M.B.A.

Professor of Orthopedics,

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sanjeev Kakar, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sanjeev Kakar, MD

Role: CONTACT

Related Links

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Other Identifiers

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15-008280

Identifier Type: -

Identifier Source: org_study_id

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