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

NCT04608916 | Completed

• 1 other identifier: MU IRB 2020
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Infection, Bacterial

Keywords

Shoulder arthroplasty; Infection; Periprosthetic joint infection; Cutibaterium acnes; Diathermy; Electrocautery

Outcome Measures

Primary Outcomes (1)

• Proportions of positive C acnes cultures

  Proportions of positive C acnes cultures

  2 weeks following surgery

Study Arms (2)

Scalpel incision group

ACTIVE COMPARATOR

This group of patients will receive skin incision made with use of a scalpel blade.

Procedure: Using scalpel blade to make skin incision

Electrocautery incision group

EXPERIMENTAL

This group of patients will receive skin incision made with use of electrocautery.

Procedure: Using surgical diathermy to make skin incision

Interventions

Using surgical diathermy to make skin incision PROCEDURE

Using surgical diathermy to make skin incision during shoulder arthroplasty

Electrocautery incision group

Using scalpel blade to make skin incision PROCEDURE

Using scaple blade to make skin incision during shoulder arthroplasty

Scalpel incision group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related Publications (10)

• Padegimas EM, Maltenfort M, Ramsey ML, Williams GR, Parvizi J, Namdari S. Periprosthetic shoulder infection in the United States: incidence and economic burden. J Shoulder Elbow Surg. 2015 May;24(5):741-6. doi: 10.1016/j.jse.2014.11.044. Epub 2015 Jan 13.

  PMID: 25595360 BACKGROUND

• van Diek FM, Pruijn N, Spijkers KM, Mulder B, Kosse NM, Dorrestijn O. The presence of Cutibacterium acnes on the skin of the shoulder after the use of benzoyl peroxide: a placebo-controlled, double-blinded, randomized trial. J Shoulder Elbow Surg. 2020 Apr;29(4):768-774. doi: 10.1016/j.jse.2019.11.027.

  PMID: 32197765 BACKGROUND

• Foruria AM, Fox TJ, Sperling JW, Cofield RH. Clinical meaning of unexpected positive cultures (UPC) in revision shoulder arthroplasty. J Shoulder Elbow Surg. 2013 May;22(5):620-7. doi: 10.1016/j.jse.2012.07.017. Epub 2012 Sep 13.

  PMID: 22981448 BACKGROUND

• Achermann Y, Sahin F, Schwyzer HK, Kolling C, Wust J, Vogt M. Characteristics and outcome of 16 periprosthetic shoulder joint infections. Infection. 2013 Jun;41(3):613-20. doi: 10.1007/s15010-012-0360-4. Epub 2012 Nov 3.

  PMID: 23124880 BACKGROUND

• Horneff JG 3rd, Hsu JE, Voleti PB, O'Donnell J, Huffman GR. Propionibacterium acnes infection in shoulder arthroscopy patients with postoperative pain. J Shoulder Elbow Surg. 2015 Jun;24(6):838-43. doi: 10.1016/j.jse.2015.03.008.

  PMID: 25979553 BACKGROUND

• Falconer TM, Baba M, Kruse LM, Dorrestijn O, Donaldson MJ, Smith MM, Figtree MC, Hudson BJ, Cass B, Young AA. Contamination of the Surgical Field with Propionibacterium acnes in Primary Shoulder Arthroplasty. J Bone Joint Surg Am. 2016 Oct 19;98(20):1722-1728. doi: 10.2106/JBJS.15.01133.

  PMID: 27869623 BACKGROUND

• Ly J, Mittal A, Windsor J. Systematic review and meta-analysis of cutting diathermy versus scalpel for skin incision. Br J Surg. 2012 May;99(5):613-20. doi: 10.1002/bjs.8708. Epub 2012 Feb 24.

  PMID: 22367850 BACKGROUND

• Ismail A, Abushouk AI, Elmaraezy A, Menshawy A, Menshawy E, Ismail M, Samir E, Khaled A, Zakarya H, El-Tonoby A, Ghanem E. Cutting electrocautery versus scalpel for surgical incisions: a systematic review and meta-analysis. J Surg Res. 2017 Dec;220:147-163. doi: 10.1016/j.jss.2017.06.093. Epub 2017 Jul 26.

  PMID: 29180177 BACKGROUND

• Kearns SR, Connolly EM, McNally S, McNamara DA, Deasy J. Randomized clinical trial of diathermy versus scalpel incision in elective midline laparotomy. Br J Surg. 2001 Jan;88(1):41-4. doi: 10.1046/j.1365-2168.2001.01625.x.

  PMID: 11136307 BACKGROUND

• Hemsell DL, Hemsell PG, Nobles B, Johnson ER, Little BB, Heard M. Abdominal wound problems after hysterectomy with electrocautery vs. scalpel subcutaneous incision. Infect Dis Obstet Gynecol. 1993;1(1):27-31. doi: 10.1155/S1064744993000079.

  PMID: 18476202 BACKGROUND

MeSH Terms

Conditions

Bacterial Infections; Infections; Fever

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 25, 2020
• First Posted: October 29, 2020
• Study Start: June 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)