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NCT Number: NCT03155854

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

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.

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Key information

Conditions

Dupuytren Contracture Connective Tissue Diseases Contracture Fibroma Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pretendinous cord excision

Procedure

The cord/palmar fascia will be excised during surgery.

Division/manipulation of the cord

Procedure

The pretendinous cord will be divided and incised during surgery.

Primary outcomes

  1. Change in Scar Progression as measured by the Vancouver Scar Scale

    Time frame: baseline, up to 1 year

    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).

  2. Change in Scar Progression as measured by the Patient and Observer Scar Assessment Scale

    Time frame: baseline, up to 1 year

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sanjeev Kakar, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
May 16, 2017
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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