Hand Incision Study

December 4, 2020 updated by: Rothman Institute Orthopaedics

Hand Surgical Incision Outcomes

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Rothman Orthopaedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
At the end of surgery, the investigator will close the incision 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
At the end of surgery, the investigator will close the incision using simple nylon sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Satisfaction with Scar Appearance (Questionnaire #1)
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rothman Institute Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 30, 2020

Primary Completion (ANTICIPATED)

November 30, 2021

Study Completion (ANTICIPATED)

November 30, 2021

Study Registration Dates

First Submitted

November 23, 2020

First Submitted That Met QC Criteria

December 4, 2020

First Posted (ACTUAL)

December 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 7, 2020

Last Update Submitted That Met QC Criteria

December 4, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • AILY20D.947

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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