Hand Incision Study

Sponsor

Rothman Institute Orthopaedics (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04656834

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hand Surgery	Procedure: hand incision closure using monocryl sutures and skin glue Procedure: hand incision closure using simple nylon sutures

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Hand Surgical Incision Outcomes

Anticipated Study Start Date :

Nov 30, 2020

Anticipated Primary Completion Date :

Nov 30, 2021

Anticipated Study Completion Date :

Nov 30, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Participant Satisfaction with Scar Appearance (Questionnaire #1) [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).
Participant Satisfaction with Scar Appearance (Questionnaire #2) [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)
Participant Satisfaction with Scar Appearance (Questionnaire #3) [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rothman Institute Orthopaedics

ClinicalTrials.gov Identifier:

NCT04656834

Other Study ID Numbers:

AILY20D.947

First Posted:

Dec 7, 2020

Last Update Posted:

Dec 7, 2020

Last Verified:

Dec 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 7, 2020