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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04656834
Other study ID # AILY20D.947
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date November 30, 2020
Est. completion date November 30, 2021

Study information

Verified date December 2020
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 80
Est. completion date November 30, 2021
Est. primary completion date November 30, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Rothman Orthopaedic Institute Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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