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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

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.

Condition or disease Intervention/treatment Phase
All Minor Hand Surgery Including Carpal Tunnel Syndrome Trigger Finger Ganglion Cysts De Quervain Syndrome Dupuytren Contracture Procedure: Absorbable Chromic gut sutures Procedure: Non-absorbable Nylon sutures Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
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
Official Title: A Randomized Controlled Trial: Nylon Versus Chromic Sutures in Hand Surgery
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : May 30, 2020


Arm Intervention/treatment
Active Comparator: 1st random 50% of cohort
Absorbable Chromic gut sutures
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.

Active Comparator: 2nd random 50% of cohort
Non-absorbable Nylon sutures
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03407820


Locations
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United States, Texas
Austin Regional Clinic
Austin, Texas, United States, 78705
HTB Musculoskeletal Institute
Austin, Texas, United States, 78712
Orthopedic Specialists of Austin
Austin, Texas, United States, 78751
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: David Ring, MD PhD University of Texas at Austin
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Responsible Party: David Ring, Associate Dean for Comprehensive Care. Professor of Surgery and Psychiatry, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT03407820    
Other Study ID Numbers: 2017-11-0021
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Ganglion Cysts
Dupuytren Contracture
Contracture
Trigger Finger Disorder
Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Tendon Entrapment
Tendinopathy
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue