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History of Changes for Study: NCT04656834
Hand Incision Study
Latest version (submitted December 4, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 4, 2020 None (earliest Version on record)
Comparison Format:

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Study NCT04656834
Submitted Date:  December 4, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: AILY20D.947
Brief Title: Hand Incision Study
Official Title: Hand Surgical Incision Outcomes
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2020
Overall Status: Unknown status [Previously: Enrolling by invitation]
Study Start: November 30, 2020
Primary Completion: November 30, 2021 [Anticipated]
Study Completion: November 30, 2021 [Anticipated]
First Submitted: November 23, 2020
First Submitted that
Met QC Criteria:
December 4, 2020
First Posted: December 7, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
December 4, 2020
Last Update Posted: December 7, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Rothman Institute Orthopaedics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Hand Surgery
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 80 [Anticipated]
Number of Groups/Cohorts 2
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
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
Open or close this module Outcome Measures
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)
Open or close this module Eligibility
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
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers:
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
Open or close this module Contacts/Locations
Locations: United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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