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Hand Incision Study

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ClinicalTrials.gov Identifier: NCT04656834
Recruitment Status : Enrolling by invitation
First Posted : December 7, 2020
Last Update Posted : December 7, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

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
Hand Surgery Procedure: hand incision closure using monocryl sutures and skin glue Procedure: hand incision closure using simple nylon sutures

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hand Surgical Incision Outcomes
Estimated Study Start Date : November 30, 2020
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021

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




Primary Outcome Measures :
  1. 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).

  2. 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)

  3. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04656834


Locations
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United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04656834    
Other Study ID Numbers: AILY20D.947
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries