Suture Closure Trial

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

Interventions

DEVICE

Monocryl buried

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.

DEVICE

Nylon (FDA Approved) not buried

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.

Sponsors & Collaborators

• Emory University

  lead OTHER

Principal Investigators

• Eric R Wagner, MD, MS · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-05

Primary Completion

2026-01-05

Completion

2026-01-05

FDA Device

Yes

Countries

• United States

Study Locations