Suture Closure Trial

NCT05261425 | Completed FDA Device

• 2 other identifiers: STUDY000022512025P013345
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

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.

Conditions

Surgical Wound; Upper Extremity Injury

Keywords

Sutures; surgical technique

Outcome Measures

Primary Outcomes (1)

• 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.

  Post-operative follow-up up to 3 months

Study Arms (2)

Monocryl buried

ACTIVE COMPARATOR

Upper extremity primary surgical wound closure via suture with Monocryl buried

Device: Monocryl buried

Nylon (FDA Approved) not buried

ACTIVE COMPARATOR

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

Device: Nylon (FDA Approved) not buried

Interventions

Monocryl buried DEVICE

Participants randomized to this group will receive the Monocryl (suture) buried (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.

Monocryl buried

Nylon (FDA Approved) not buried DEVICE

Participants randomized to this group will receive the Nylon (FDA Approved) (suture), not buried (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.

Nylon (FDA Approved) not buried

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

Emory Orthopedic and Spine Hospital

Atlanta, Georgia, 30084, United States

Location

Emory Executive Park

Atlanta, Georgia, 30329, United States

Location

Emory Orthopaedics and Spine Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Surgical Wound; Arm Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Eric R Wagner, MD, MS

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: March 2, 2022
• Study Start: February 5, 2024
• Primary Completion: January 5, 2026
• Study Completion: January 5, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)