Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sutures Versus Staples for Wound Closure in Orthopaedic Surgery

NCT01146236

Surgical Wound Infection

COMPLETED NA

Suture Closure Trial

NCT05261425

Surgical Wound Upper Extremity Injury

ACTIVE_NOT_RECRUITING NA

Outcomes Comparing Different Methods of Skin Closure in Patients Undergoing Head and Neck Surgery.

NCT02936063

Surgical Wound

WITHDRAWN NA

Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients

NCT02143336

Surgical Wound Infections Colorectal Surgery

UNKNOWN NA

Study of Sutures Versus Staples for Skin Closure After Surgical Procedures of Hip

NCT00273715

Surgery

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lower Extremity Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Suture

Wound Closure

Group Type OTHER

Suture

Intervention Type OTHER

Wound Closure

Staple

Wound Closure

Group Type OTHER

Staple

Intervention Type OTHER

Wound Closure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Suture

Wound Closure

Intervention Type OTHER

Staple

Wound Closure

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No