CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 64 enrolled
Drug / intervention
Using surgical diathermy to make skin incision +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04608916
NCT04608916N/ACompleted

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

University of Missouri-Columbia·interventional·Posted Oct 29, 2020·Updated Apr 11, 2023

In Brief

A clinical study evaluating Using surgical diathermy to make skin incision and Using scalpel blade to make skin incision for Infection, Bacterial. Completed, enrolled 64 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedOct 29, 2020
Enrollment StartJun 1, 2021
Primary CompletionNov 1, 2022
Study CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.7 years ago

Interventions

Using surgical diathermy to make skin incisionprocedure

Using surgical diathermy to make skin incision during shoulder arthroplasty

Using scalpel blade to make skin incisionprocedure

Using scaple blade to make skin incision during shoulder arthroplasty