Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery (SvS)

University of Southern California

Status: Enrolling

Conditions: Lower Extremity Fracture

Treatments: Other: Suture; Other: Staple

Study type: Interventional

Funder types: Other

Identifiers

NCT06586814

HS-24-00012

Details and patient eligibility

About

This pilot study is designed to assess the feasibility of comparing skin closure methods - sutures versus staples - and subsequent rates of surgical site infection following open reduction and internal fixation surgery for orthopaedic trauma injuries. The primary objectives are to determine if enrollment, randomization, and compliance are feasible and to refine data collection methods. Patients =18 years of age with closed fractures of the tibial plateau, tibial pilon, patella, and distal femur presenting within 3 weeks of injury undergoing definitive treatment of their fracture will be approached for participation. If enrolled, they will be randomized to having their surgical wound closed with either nylon sutures or metallic staples. Patient follow up will be standard of care besides answering PROMIS surveys.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult Patients 18-80 years old
• Tibial Pilon, Tibial Plateau Fractures, Patella Fractures, and Distal Femur Fractures
• Incisions must be able to be approximated with subdermal sutures intraoperatively
• English and Spanish speaking patients only

Exclusion criteria

• Open fractures
• Incarcerated patients
• Pregnant patients
• Patients who do not speak English or Spanish
• History of infection at surgical incision site at the time of definitive fixation
• Pre-existing skin condition associated with risk of infection (psoriasis, eczema)
• Unable to obtain consent from patient prior to surgery or from legally authorized representative (LAR) prior to skin closure if the patient is unable to consent dur to their medical condition.
• The absence of a subcutaneous closure during the index procedure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Suture

Other group

Description:

Wound Closure

Treatment:

Other: Suture

Staple

Other group

Description:

Wound Closure

Treatment:

Other: Staple