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Suture Closure Trial

Primary Purpose

Surgical Wound, Upper Extremity Injury

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Monocryl (FDA Approved) buried running
Monocryl buried interrupted
Monocryl not buried interrupted
Monocryl not buried running
Gut (FDA Approved) not buried interrupted
Nylon (FDA Approved) not buried interrupted
Nylon not buried running
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Wound focused on measuring Sutures, surgical technique

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients undergoing surgery for upper extremity injury (finger, hand, wrist, elbow, shoulder)
  • Patients aged 18 to 99-years-old who are willing and able to provide informed consent

Exclusion Criteria:

  • Adults unable to give consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

Sites / Locations

  • Emory Orthopedic and Spine Hospital
  • Emory Executive Park
  • Emory Orthopaedics and Spine Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Monocryl (FDA Approved) buried running

Monocryl buried interrupted

Monocryl not buried interrupted

Monocryl not buried running

Gut (FDA Approved) not buried interrupted

Nylon (FDA Approved) not buried interrupted

Nylon not buried running

Arm Description

Upper extremity primary surgical wound closure via suture with Monocryl (FDA Approved) buried running

Upper extremity primary surgical wound closure via suture with Monocryl buried interrupted

Upper extremity primary surgical wound closure via suture with Monocryl not buried interrupted

Upper extremity primary surgical wound closure via suture with Monocryl not buried running

Upper extremity primary surgical wound closure via suture with Gut (FDA Approved) not buried interrupted

Upper extremity primary surgical wound closure via suture with Nylon (FDA Approved) not buried interrupted

Upper extremity primary surgical wound closure via suture with Nylon not buried running

Outcomes

Primary Outcome Measures

Change in participant's pain score
Participants will be asked to complete questionnaires to evaluate their pain at each follow-up visit. The Visual Analog Scale will be the subjective measurement to evaluate changes in pain scores, with values ranging from 0 (no pain) to 10 (very severe pain). A higher score indicates worse pain.

Secondary Outcome Measures

Full Information

First Posted
January 4, 2022
Last Updated
July 5, 2023
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT05261425
Brief Title
Suture Closure Trial
Official Title
Incision Closure for Orthopedic Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Closure of surgical incisions in orthopedic procedures contributes to patient postoperative pain and risk of complication. As the focus on improving orthopedic surgery outcomes shifts to best practices in postoperative pain management, it is important to consider suture types and techniques. This study specifically would focus on comparing different suture types and techniques and their efficacy. This will be a randomized controlled trial comparing currently used, standard of care suture types and currently used, standard of care suture techniques to identify differences, if any exist, in postoperative pain scores and wound healing as assessed by exam and postoperative patient surveys. Patients will be identified by the Emory Upper Extremity/Hand Surgeons as they are identified as a candidate for surgery. Participants will then be informed of the study and spoken to about the specifics of the study. The research team will consent and recruit patients either in The Emory Clinic or in the preoperative area prior to surgery. All surgical operations will take place at the ambulatory surgical center in The Emory Clinic or at the Emory University Orthopaedic and Spine Hospital. Patients will not be compensated for participation in this study. No specimens/data/samples will be collected and stored for later use, and there are no optional substudies. This proposed study will address the lack of published literature regarding the suture technique in hand and wrist surgery in particular. Combined with examining various suture materials, the proposal has the potential to provide a valuable and actionable base of knowledge to the current body of literature.
Detailed Description
The purpose of this study is to evaluate the efficacy of different standard-of-care FDA Approved suture types and techniques. The use of sutures in primary closure of surgical incisions is standard of care for all surgical specialties, including surgery of the hand and wrist. When controlling for type of wound, wound depth, and desired tension, the type of suture selected and technique in which it is applied may vary depending on factors such as surgeon preference and training background. Addressing different suture types: A variety of suture types are currently in use as the standard of care for the closure of surgical incisions. These are primarily categorized by the composition of absorbable and non-absorbable materials, and further by subtype into braided (vicryl and vicryl Rapide absorbable; ethibond and silk non-absorbable) versus monofilament suture structure (monocryl, polydioxanone, and gut absorbable; ethilon and prolene non-absorbable), or alternatively by synthetic versus natural material composition. As suture types vary in their elasticity, plasticity, memory, and tensile strength, there have been multiple studies assessing the difference in various outcomes between the use of absorbable and non-absorbable suture materials for incision closure after wrist and hand surgery, predominantly after carpal tunnel release. Addressing different suture techniques: There is significantly less evidence regarding different suturing techniques for incision closure after upper extremity surgery. In fact, there exist no studies assessing outcomes from different suture techniques for hand or wrist surgery at all. This proposed study will address the lack of published literature regarding the suture technique in hand and wrist surgery in particular. Combined with examining various suture materials, the proposal has the potential to provide a valuable and actionable base of knowledge to the current body of literature. The research team will randomize patients at each endpoint into cohorts for their orthopedic upper extremity surgical procedure. The PI/Co-Investigators will provide primary closure via suture in the operating room with the cooperation of their surgical team to the normal standard of care for wound closure. The research team will coordinate with scrub technicians and nursing staff to ensure that each patient receives the correctly randomized suture or technique for closure by the surgeon. The patient will then be asked questionnaires to evaluate their satisfaction with their wound closure and will be assessed by the surgeon as well. The study device sutures will continue to be stored in the operating room and will only be accessed at the time of surgery following standard of care operating protocols

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound, Upper Extremity Injury
Keywords
Sutures, surgical technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monocryl (FDA Approved) buried running
Arm Type
Active Comparator
Arm Description
Upper extremity primary surgical wound closure via suture with Monocryl (FDA Approved) buried running
Arm Title
Monocryl buried interrupted
Arm Type
Active Comparator
Arm Description
Upper extremity primary surgical wound closure via suture with Monocryl buried interrupted
Arm Title
Monocryl not buried interrupted
Arm Type
Active Comparator
Arm Description
Upper extremity primary surgical wound closure via suture with Monocryl not buried interrupted
Arm Title
Monocryl not buried running
Arm Type
Active Comparator
Arm Description
Upper extremity primary surgical wound closure via suture with Monocryl not buried running
Arm Title
Gut (FDA Approved) not buried interrupted
Arm Type
Active Comparator
Arm Description
Upper extremity primary surgical wound closure via suture with Gut (FDA Approved) not buried interrupted
Arm Title
Nylon (FDA Approved) not buried interrupted
Arm Type
Active Comparator
Arm Description
Upper extremity primary surgical wound closure via suture with Nylon (FDA Approved) not buried interrupted
Arm Title
Nylon not buried running
Arm Type
Active Comparator
Arm Description
Upper extremity primary surgical wound closure via suture with Nylon not buried running
Intervention Type
Device
Intervention Name(s)
Monocryl (FDA Approved) buried running
Intervention Description
Participants randomized to this group will receive the Monocryl (FDA Approved) (suture) buried running (technique). The surgeon will utilize the randomized material and technique and the research team will utilize two surveys postoperatively to assess wound healing and appearance. Participants will fill out these surveys at each of their clinical follow-up visits.
Intervention Type
Device
Intervention Name(s)
Monocryl buried interrupted
Intervention Description
Participants randomized to this group will receive the Monocryl (suture) buried interrupted (technique). The surgeon will utilize the randomized material and technique and the research team will utilize two surveys postoperatively to assess wound healing and appearance. Participants will fill out these surveys at each of their clinical follow-up visits.
Intervention Type
Device
Intervention Name(s)
Monocryl not buried interrupted
Intervention Description
Participants randomized to this group will receive the Monocryl (suture) not buried interrupted (technique). The surgeon will utilize the randomized material and technique and the research team will utilize two surveys postoperatively to assess wound healing and appearance. Participants will fill out these surveys at each of their clinical follow-up visits.
Intervention Type
Device
Intervention Name(s)
Monocryl not buried running
Intervention Description
Participants randomized to this group will receive the Monocryl (suture) not buried running (technique). The surgeon will utilize the randomized material and technique and the research team will utilize two surveys postoperatively to assess wound healing and appearance. Participants will fill out these surveys at each of their clinical follow-up visits.
Intervention Type
Device
Intervention Name(s)
Gut (FDA Approved) not buried interrupted
Intervention Description
Participants randomized to this group will receive the Gut (FDA Approved) (suture) not buried interrupted (technique). The surgeon will utilize the randomized material and technique and the research team will utilize two surveys postoperatively to assess wound healing and appearance. Participants will fill out these surveys at each of their clinical follow-up visits.
Intervention Type
Device
Intervention Name(s)
Nylon (FDA Approved) not buried interrupted
Intervention Description
Participants randomized to this group will receive the Nylon (FDA Approved) (suture) not buried interrupted (technique). The surgeon will utilize the randomized material and technique and the research team will utilize two surveys postoperatively to assess wound healing and appearance. Participants will fill out these surveys at each of their clinical follow-up visits.
Intervention Type
Device
Intervention Name(s)
Nylon not buried running
Intervention Description
Participants randomized to this group will receive Nylon not buried running as the suture and technique. The surgeon will utilize the randomized material and technique and the research team will utilize two surveys postoperatively to assess wound healing and appearance. Participants will fill out these surveys at each of their clinical follow-up visits.
Primary Outcome Measure Information:
Title
Change in participant's pain score
Description
Participants will be asked to complete questionnaires to evaluate their pain at each follow-up visit. The Visual Analog Scale will be the subjective measurement to evaluate changes in pain scores, with values ranging from 0 (no pain) to 10 (very severe pain). A higher score indicates worse pain.
Time Frame
Post-operative follow-up up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients undergoing surgery for upper extremity injury (finger, hand, wrist, elbow, shoulder) Patients aged 18 to 99-years-old who are willing and able to provide informed consent Exclusion Criteria: Adults unable to give consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric R Wagner, MD, MS
Phone
404-778-7249
Email
eric.r.wagner@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric R Wagner, MD, MS
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Orthopedic and Spine Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric R Wagner, MD, MS
Phone
404-778-7249
Email
eric.r.wagner@emory.edu
Facility Name
Emory Executive Park
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Emory Orthopaedics and Spine Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix Gonzalez, MD
Phone
404-778-5834
Email
felix.m.gonzalez@emory.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Suture Closure Trial

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