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Different Sutures in Hand Surgery

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: NCT03407820
Recruitment Status : Active, not recruiting
First Posted : January 23, 2018
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
David Ring, University of Texas at Austin

Tracking Information
First Submitted Date  ICMJE January 8, 2018
First Posted Date  ICMJE January 23, 2018
Last Update Posted Date December 26, 2019
Actual Study Start Date  ICMJE January 31, 2018
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
Treatment satisfaction measured on an 11-point ordinal scale [ Time Frame: Four weeks after surgery ]
The scale ranges from 0 to 10, with higher scores representing higher treatment satisfaction.
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2018)
Treatment satisfaction measured on an 11-point ordinal scale [ Time Frame: Four weeks after surgery ]
Null hypothesis: There is no association between patients' overall mean treatment satisfaction (measured on an 11-point ordinal scale) and type of suture used (absorbable versus non-absorbable). The scale ranges from 0 to 10, with higher scores representing higher treatment satisfaction.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
  • Factors associated with wound concerns within one month of surgery [ Time Frame: Four weeks after surgery ]
    Factors will include patient demographic factors such as age, sex, race/ethnicity, level of education. Wound concerns will be assessed by number of contacts with questions for wound concerns.
  • Factors associated with pain intensity (11 point ordinal scale) within one month of surgery [ Time Frame: Four weeks after surgery ]
    Factors will include patient demographic factors such as age, sex, race/ethnicity, level of education. The scale ranges from 0 to 10, with higher scores representing higher pain intensity.
  • Factors associated with magnitude of limitations (with PROMIS-UE PF) within one month of surgery [ Time Frame: Four weeks after surgery ]
    Factors will include patient demographic factors such as age, sex, race/ethnicity, level of education. PROMIS-UE PF scores are reported as T-scores with a mean of 50 and SD of 10, with higher scores representing higher levels of physical function.
  • Factors associated with scar satisfaction (11 point ordinal scale) within one month of surgery [ Time Frame: Four weeks after surgery ]
    Factors will include patient demographic factors such as age, sex, race/ethnicity, level of education. The scale ranges from 0 to 10, with higher scores representing higher scar satisfaction.
  • Difference in treatment satisfaction between patients rating 0-8 and 9-10 on an 11-point ordinal scale [ Time Frame: Four weeks after surgery ]
    he scale ranges from 0 to 10, with higher scores representing higher treatment satisfaction.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2018)
  • Factors associated with wound concerns within one month of surgery [ Time Frame: Four weeks after surgery ]
    Null hypothesis: There are no independent factors associated with wound concerns within one month of surgery. Factors will include patient demographic factors such as age, sex, race/ethnicity, level of education. Wound concerns will be assessed by number of contacts with questions for wound concerns.
  • Factors associated with pain intensity (11 point ordinal scale) within one month of surgery [ Time Frame: Four weeks after surgery ]
    Null hypothesis: There are no independent factors associated with pain intensity (11 point ordinal scale) one month after surgery. Factors will include patient demographic factors such as age, sex, race/ethnicity, level of education. The scale ranges from 0 to 10, with higher scores representing higher pain intensity.
  • Factors associated with magnitude of limitations (with PROMIS-UE PF) within one month of surgery [ Time Frame: Four weeks after surgery ]
    Null hypothesis: There are no independent factors associated with magnitude of limitations (with PROMIS-UE PF) one month after surgery. Factors will include patient demographic factors such as age, sex, race/ethnicity, level of education. PROMIS-UE PF scores are reported as T-scores with a mean of 50 and SD of 10, with higher scores representing higher levels of physical function.
  • Factors associated with scar satisfaction (11 point ordinal scale) within one month of surgery [ Time Frame: Four weeks after surgery ]
    Null hypothesis: There are no independent factors associated with scar satisfaction (11 point ordinal scale) one month after surgery. Factors will include patient demographic factors such as age, sex, race/ethnicity, level of education. The scale ranges from 0 to 10, with higher scores representing higher scar satisfaction.
  • Difference in treatment satisfaction between patients rating 0-8 and 9-10 on an 11-point ordinal scale [ Time Frame: Four weeks after surgery ]
    Null hypothesis: There is no difference in the percentage of patients rating 9 or 10 versus the percentage of patients rating <9 for overall treatment satisfaction. The scale ranges from 0 to 10, with higher scores representing higher treatment satisfaction.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Different Sutures in Hand Surgery
Official Title  ICMJE A Randomized Controlled Trial: Nylon Versus Chromic Sutures in Hand Surgery
Brief Summary This study aims to assess the relationship between overall satisfaction with treatment in a group of randomized patients undergoing elective hand surgery using either absorbable (4-0 Chromic) or non-absorbable (5-0 Nylon) sutures. The investigators will also assess factors associated with wound concerns, pain intensity, magnitude of limitations, and physical function within one month of surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description:
Both patient and surgeon will be blinded until just before the start of the procedure.
Primary Purpose: Treatment
Condition  ICMJE
  • All Minor Hand Surgery Including
  • Carpal Tunnel Syndrome
  • Trigger Finger
  • Ganglion Cysts
  • De Quervain Syndrome
  • Dupuytren Contracture
Intervention  ICMJE
  • Procedure: Absorbable Chromic gut sutures
    In this group interrupted simple or horizontal mattress skin sutures are used for wound closure per surgeon preference. Standardized wound care instructions will be given to all patients. Those who received absorbable Chromic sutures are treated recording to the standard protocol and they are advised that they can start to gently rub the scab and suture line to encourage the sutures to fall off starting 10-14 days postoperatively.
  • Procedure: Non-absorbable Nylon sutures
    In this group interrupted simple or horizontal mattress skin sutures are used for wound closure per surgeon preference. Standardized wound care instructions will be given to all patients. Those who received Nylon sutures are treated recording to the standard protocol and sutures are removed after the usual time (10-14 days) of the received procedure.
Study Arms  ICMJE
  • Active Comparator: 1st random 50% of cohort
    Absorbable Chromic gut sutures
    Intervention: Procedure: Absorbable Chromic gut sutures
  • Active Comparator: 2nd random 50% of cohort
    Non-absorbable Nylon sutures
    Intervention: Procedure: Non-absorbable 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  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 15, 2018)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2020
Estimated Primary Completion Date May 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients undergoing common day-case elective hand surgery under local anesthesia, one of the following (initial) procedures:

    • Carpal tunnel release
    • Trigger finger release
    • Ganglion excision
    • Excisional biopsy
    • De Quervain release
    • Dupuytren fasciectomy
    • Any other minor hand surgery
  • Patients aged 18-89
  • Able to provide informed consent
  • Able to understand English or Spanish to complete questionnaires
  • Patients who have an email-address or phone number (needed for follow-up)
  • UT Health Austin Musculoskeletal Institute, Austin Regional Clinic, Orthopaedic Specialists of Austin.
  • Available for follow-up contact after 4 weeks

Exclusion Criteria:

  • Patients not able to give informed consent
  • Patients using corticosteroids
  • Patients with one of the following comorbidities: bleeding disorder, immunodeficiency, collagen vascular disease.
  • Patients known to be allergic to suture materials
  • Revision procedures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03407820
Other Study ID Numbers  ICMJE 2017-11-0021
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  ICMJE
Plan to Share IPD: No
Responsible Party David Ring, University of Texas at Austin
Study Sponsor  ICMJE University of Texas at Austin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Ring, MD PhD University of Texas at Austin
PRS Account University of Texas at Austin
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP