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Different Sutures in Hand Surgery

Primary Purpose

All Minor Hand Surgery Including, Carpal Tunnel Syndrome, Trigger Finger

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Absorbable Chromic gut sutures
Non-absorbable Nylon sutures
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for All Minor Hand Surgery Including

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Austin Regional Clinic
  • HTB Musculoskeletal Institute
  • Orthopedic Specialists of Austin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1st random 50% of cohort

2nd random 50% of cohort

Arm Description

Absorbable Chromic gut sutures

Non-absorbable Nylon sutures

Outcomes

Primary Outcome Measures

Treatment satisfaction measured on an 11-point ordinal scale
The scale ranges from 0 to 10, with higher scores representing higher treatment satisfaction.

Secondary Outcome Measures

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
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
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
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
he scale ranges from 0 to 10, with higher scores representing higher treatment satisfaction.

Full Information

First Posted
January 8, 2018
Last Updated
December 24, 2019
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT03407820
Brief Title
Different Sutures in Hand Surgery
Official Title
A Randomized Controlled Trial: Nylon Versus Chromic Sutures in Hand Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
May 30, 2020 (Anticipated)
Study Completion Date
May 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
All Minor Hand Surgery Including, Carpal Tunnel Syndrome, Trigger Finger, Ganglion Cysts, De Quervain Syndrome, Dupuytren Contracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Both patient and surgeon will be blinded until just before the start of the procedure.
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1st random 50% of cohort
Arm Type
Active Comparator
Arm Description
Absorbable Chromic gut sutures
Arm Title
2nd random 50% of cohort
Arm Type
Active Comparator
Arm Description
Non-absorbable Nylon sutures
Intervention Type
Procedure
Intervention Name(s)
Absorbable Chromic gut sutures
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Non-absorbable Nylon sutures
Intervention Description
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 Measure Information:
Title
Treatment satisfaction measured on an 11-point ordinal scale
Description
The scale ranges from 0 to 10, with higher scores representing higher treatment satisfaction.
Time Frame
Four weeks after surgery
Secondary Outcome Measure Information:
Title
Factors associated with wound concerns within one month of surgery
Description
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.
Time Frame
Four weeks after surgery
Title
Factors associated with pain intensity (11 point ordinal scale) within one month of surgery
Description
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.
Time Frame
Four weeks after surgery
Title
Factors associated with magnitude of limitations (with PROMIS-UE PF) within one month of surgery
Description
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.
Time Frame
Four weeks after surgery
Title
Factors associated with scar satisfaction (11 point ordinal scale) within one month of surgery
Description
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.
Time Frame
Four weeks after surgery
Title
Difference in treatment satisfaction between patients rating 0-8 and 9-10 on an 11-point ordinal scale
Description
he scale ranges from 0 to 10, with higher scores representing higher treatment satisfaction.
Time Frame
Four weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ring, MD PhD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Austin Regional Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
HTB Musculoskeletal Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Facility Name
Orthopedic Specialists of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Different Sutures in Hand Surgery

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