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

Primary Purpose

Infection, Bacterial

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Using surgical diathermy to make skin incision
Using scalpel blade to make skin incision
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection, Bacterial focused on measuring Shoulder arthroplasty, Infection, Periprosthetic joint infection, Cutibaterium acnes, Diathermy, Electrocautery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Scalpel incision group

Electrocautery incision group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Proportions of positive C acnes cultures
Proportions of positive C acnes cultures

Secondary Outcome Measures

Full Information

First Posted
October 25, 2020
Last Updated
April 10, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04608916
Brief Title
Efficacy of Surgical Diathermy in Eradicating Cutibacterium Acnes From Surgical Skin Incision During Shoulder Arthroplasty
Acronym
Electrocautery
Official Title
Efficacy of Surgical Diathermy in Eradicating Cutibacterium Acnes From Surgical Skin Incision During Shoulder Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Periprosthetic infection following shoulder arthroplasty is a devastating complication. Infected shoulder arthroplasty not only causes an unexpected health hazard to patients but also imposes a heavy financial burden at both individual and societal levels. The rates of periprosthetic shoulder infection (PSI) have been reported to be 0.80% to 1.46%, but the number of infections is likely to increase as shoulder arthroplasty becomes more commonplace in an aging active population. Diagnosing and treating PSI poses a significant challenge. Unlike periprosthetic infection in other joints, PSI lacks the typical clinical signs and laboratory findings of infection due to the indolent nature of the offending pathogens. At the forefront of this issue is Cutibacterium acnes. Although the typical Staphylococcus, Streptococcus, and Corynebacterium species that reside on the skin surface are the primary targets of most surgical infection prophylaxis regimens, C acnes has emerged as a problematic bacterium because the current prophylactic regimens are insufficient to eradicate C acnes from the surgical field. C acnes is one of the most common pathogens of infections after shoulder surgery. It is a commensal, gram-positive anaerobic bacillus that resides in the sebaceous glands associated with hair follicles. The colonization with C acnes of the front and back side of the shoulder epidermis is greater than that of other regions of the body because of the high density of the sebaceous glands in that area. C acnes can cause low-grade infections after shoulder surgery, and it has been shown that it is the most commonly detected bacterium after revision shoulder arthroplasty surgery. During revision shoulder arthroscopy cases performed for pain, stiffness, or weakness, 30% of patients had positive culture findings, and 80% of those findings were positive for C acnes. 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. Recent studies showed that hydrogen peroxide and benzoyl peroxide were more effective than the conventional skin preparation methods in decreasing the C acnes load in the skin, but as high as 17% of the cultures were still positive for C acnes even with these new measures. Thus, despite all the efforts to eradicate C acnes from the shoulder, C acnes remain an elusive pathogen that is potentially contaminating tens of thousands of shoulder arthroplasties each year. Surgical diathermy (or electrocautery) has been used routinely for tissue dissection and hemostasis during surgical procedures. In the cutting mode, the use of an electrode delivering a pure continuous sinusoidal wave of low voltage produces as high temperatures as 1000℃, which heats cells within the tissue so rapidly that they vaporize, leaving a cavity within the cell matrix. The heat created dissipates as a stream rather than being transmitted into adjacent tissues. This allows tissue cleavage without damage to surrounding areas. The electrode does not need to be in contact with tissue as an arc is formed producing a clean cut. With the coagulation mode on high power, cutting also occurs, but this produces a larger zone of greater thermal damage. Electrocautery can be used for dissecting fascia and muscle layers, as well as achieving hemostasis, and it has become an integral part of modern surgical practice. A number of clinical studies evaluated the safety and efficacy of cutting electrocautery for surgical incisions in general, plastic, otorhinolaryngological, orthopedic, neurosurgical, and gynecologic procedures. Additionally, systematic reviews and meta-analyses were conducted for the same purposes. The majority of these studies showed that using electrocautery to cut the skin provided the benefits of reduced bleeding, a quicker incision, and decreased postoperative pain with no increase of wound complications when compared to scalpel incisions. Given the high temperatures generated at the tip of an electrode of electrocautery, it is reasonable to assume that making a skin incision with electrocautery could potentially destroy exposed colonies of C acnes in hair follicles and sebaceous glands open on the incisional surface of the skin. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Bacterial
Keywords
Shoulder arthroplasty, Infection, Periprosthetic joint infection, Cutibaterium acnes, Diathermy, Electrocautery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scalpel incision group
Arm Type
Active Comparator
Arm Description
This group of patients will receive skin incision made with use of a scalpel blade.
Arm Title
Electrocautery incision group
Arm Type
Experimental
Arm Description
This group of patients will receive skin incision made with use of electrocautery.
Intervention Type
Procedure
Intervention Name(s)
Using surgical diathermy to make skin incision
Intervention Description
Using surgical diathermy to make skin incision during shoulder arthroplasty
Intervention Type
Procedure
Intervention Name(s)
Using scalpel blade to make skin incision
Intervention Description
Using scaple blade to make skin incision during shoulder arthroplasty
Primary Outcome Measure Information:
Title
Proportions of positive C acnes cultures
Description
Proportions of positive C acnes cultures
Time Frame
2 weeks following surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD with other researchers
Citations:
PubMed Identifier
25595360
Citation
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.
Results Reference
background
PubMed Identifier
32197765
Citation
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.
Results Reference
background
PubMed Identifier
22981448
Citation
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.
Results Reference
background
PubMed Identifier
23124880
Citation
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.
Results Reference
background
PubMed Identifier
25979553
Citation
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.
Results Reference
background
PubMed Identifier
27869623
Citation
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.
Results Reference
background
PubMed Identifier
22367850
Citation
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.
Results Reference
background
PubMed Identifier
29180177
Citation
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.
Results Reference
background
PubMed Identifier
11136307
Citation
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.
Results Reference
background
PubMed Identifier
18476202
Citation
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.
Results Reference
background

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

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