We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04608916
Recruitment Status : Recruiting
First Posted : October 29, 2020
Last Update Posted : March 25, 2022
Sponsor:
Information provided by (Responsible Party):
H. Mike Kim, University of Missouri-Columbia

Brief 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

Condition or disease Intervention/treatment Phase
Infection, Bacterial Procedure: Using surgical diathermy to make skin incision Procedure: Using scalpel blade to make skin incision Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Surgical Diathermy in Eradicating Cutibacterium Acnes From Surgical Skin Incision During Shoulder Arthroplasty
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Active Comparator: Scalpel incision group
This group of patients will receive skin incision made with use of a scalpel blade.
Procedure: Using scalpel blade to make skin incision
Using scaple blade to make skin incision during shoulder arthroplasty

Experimental: Electrocautery incision group
This group of patients will receive skin incision made with use of electrocautery.
Procedure: Using surgical diathermy to make skin incision
Using surgical diathermy to make skin incision during shoulder arthroplasty




Primary Outcome Measures :
  1. Proportions of positive C acnes cultures [ Time Frame: 2 weeks following surgery ]
    Proportions of positive C acnes cultures



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male patients (>18 years old) who undergo primary shoulder arthroplasty (either anatomic or reverse shoulder arthroplasty)

Exclusion Criteria:

  • History of ipsilateral shoulder postoperative infection
  • Administration of any antibiotics within a month prior to the index procedure
  • Active acne at the surgical site
  • History of psoriatic or eczematous lesions about the shoulder area
  • Revision arthroplasty cases
  • Minors (< 18 years old)
  • Female patients
  • Prisoners
  • Patients who cannot understand English enough to give an informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04608916


Locations
Layout table for location information
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Contact: Susan Kady, BSN, RN    573-882-3181    irb@missouri.edu   
Sponsors and Collaborators
University of Missouri-Columbia
Publications:

Layout table for additonal information
Responsible Party: H. Mike Kim, Associate Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT04608916    
Other Study ID Numbers: MU IRB 2020
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: March 25, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD with other researchers

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Mike Kim, University of Missouri-Columbia:
Shoulder arthroplasty
Infection
Periprosthetic joint infection
Cutibaterium acnes
Diathermy
Electrocautery
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Bacterial Infections
Hyperthermia
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries
Bacterial Infections and Mycoses