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Hand Incision Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 23, 2020
First Posted Date December 7, 2020
Last Update Posted Date December 7, 2020
Estimated Study Start Date November 30, 2020
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 4, 2020)
  • 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).
  • 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)
  • 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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Hand Incision Study
Official Title Hand Surgical Incision Outcomes
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 Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Hand Surgery
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
  • Procedure: hand incision closure using simple nylon sutures
    At the end of surgery, the investigator will close the incision using simple nylon sutures
Study Groups/Cohorts
  • 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
    Intervention: Procedure: hand incision closure 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
    Intervention: Procedure: hand incision closure using simple nylon sutures
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: December 4, 2020)
80
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2021
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04656834
Other Study ID Numbers AILY20D.947
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Rothman Institute Orthopaedics
Original Responsible Party Same as current
Current Study Sponsor Rothman Institute Orthopaedics
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date December 2020