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Efficacy of Surgical Diathermy in Eradicating Cutibacterium Acnes From Surgical Skin Incision During Shoulder Arthroplasty

NCT04608916 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-04-11

No results posted yet for this study

Summary

Periprosthetic infection following shoulder arthroplasty is a devastating complication. Diagnosing and treating periprosthetic shoulder infection poses a significant challenge. At the forefront of this issue is Cutibacterium acnes because the current prophylactic regimens are insufficient to eradicate C acnes from the surgical field. It is believed that C acnes infections occur during surgery when the sebaceous glands in the skin are cut and exposed, leading to C acnes contaminating the surgeon's instruments and gloves and, thus, the surgical wound. The purpose of this study is to examine if making skin incisions using electrocautery will result in decreased C acnes contamination during shoulder arthroplasty. To this end, we propose a randomized clinical trial where patients undergoing shoulder arthroplasty are randomized into two groups - Electrocautery incision group (Electro) vs. Scalpel incision group (Scalpel) - and swab cultures are obtained from the skin incision and operating surgeon's gloves and forceps

Conditions

  • Infection, Bacterial

Interventions

PROCEDURE

Using surgical diathermy to make skin incision

Using surgical diathermy to make skin incision during shoulder arthroplasty

PROCEDURE

Using scalpel blade to make skin incision

Using scaple blade to make skin incision during shoulder arthroplasty

Sponsors & Collaborators

  • University of Missouri-Columbia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-11-01
Completion
2022-12-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04608916 on ClinicalTrials.gov