NCT04656834

Brief Summary

The cosmetic outcome of a patient's surgical scar is important for patient satisfaction, especially in more visibly exposed areas of the body such as the hand. A patient's surgical scar often serves as a long-term reminder of their surgery experience, so optimizing final scar appearance should be of high importance. Surgical incision closure techniques and suture materials may vary by individual hand surgeons, even with common hand procedures.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

December 7, 2020

Status Verified

December 1, 2020

Enrollment Period

1 year

First QC Date

November 23, 2020

Last Update Submit

December 4, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Participant Satisfaction with Scar Appearance (Questionnaire #1)

    Participant will be asked to answer a series of questions regarding the cosmetic appearance of their surgical scar and how satisfied they are with the appearance of the scar as measured by the Patient Scar Assessment Questionnaire (PSAQ).

    12 weeks

  • Participant Satisfaction with Scar Appearance (Questionnaire #2)

    Participant will be asked to answer a series of questions regarding the cosmetic appearance of their surgical scar and how satisfied they are with the appearance of the scar as measured by the Stony Brook Scar Evaluation Scale (SBSES)

    12 weeks

  • Participant Satisfaction with Scar Appearance (Questionnaire #3)

    Participant will be asked to answer a series of questions regarding the cosmetic appearance of their surgical scar and how satisfied they are with the appearance of the scar as measured by the Visual Analog Scale (VAS)

    12 weeks

Study Arms (2)

Hand incision closure type 1

The participating surgeon closes the hand surgical incision via the standard method based on personal preference: buried monocryl sutures and skin glue

Procedure: hand incision closure using monocryl sutures and skin glue

Hand incision closure type 2

The participating surgeon closes the hand surgical incision via the standard method based on personal preference: simple nylon sutures

Procedure: hand incision closure using simple nylon sutures

Interventions

At the end of surgery, the investigator will close the incision using monocryl sutures and skin glue

Hand incision closure type 1

At the end of surgery, the investigator will close the incision using simple nylon sutures

Hand incision closure type 2

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants who are 18 years old or older who are having surgery for either a trigger finger release or carpal tunnel release by one of Rothman Orthopaedics Hand \& Wrist Surgeons

You may qualify if:

  • Patients ≥ 18 years old
  • Able to provide consent
  • Undergoing either trigger finger release or carpal tunnel release

You may not qualify if:

  • Patients \< 18 years old
  • Unable to provide consent
  • Unable to comply with follow up requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2020

First Posted

December 7, 2020

Study Start

November 30, 2020

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

December 7, 2020

Record last verified: 2020-12

Locations