Hydrogen Peroxide to the Wound Following Surgical Incision Affecting Cultures in Primary Shoulder Arthroplast

How Does Hydrogen Peroxide Application to the Wound Following Surgical Incision Affect C. Acnes Cultures in Primary Shoulder Arthroplasty?

Cutibacterium acnes has been the focus of much recent shoulder literature, as it has been found to be both a common cause of periprosthetic joint infection as well as a common contaminant in shoulder surgery. Standard skin preparations have been found to be ineffective at eradicating C. acnes colonization on the skin and deep dermis of patients undergoing surgery. Recent literature has shown that skin preparation with 3% hydrogen peroxide solution is effective for decreasing the rate of cultures positive for C. acnes in both dermal and deep cultures; however, a positive rate of 10%-17% has still been reported despite this skin preparations. The current theory is that standard skin preparation does not remove C. acnes from the deep dermis which subsequently contaminates the deep tissue. We hypothesize that application of 3% hydrogen peroxide to the deep dermal layer immediately following the skin incision will even further decrease the rate of C. acnes contamination during surgery.

Study Overview

• Status: Active, not recruiting
• Conditions: Primary Anatomic or Reverse Total Shoulder Arthroplasty
• Intervention / Treatment: Other: H2O2 application to incision

Detailed Description

Over 50,000 people in the United States have shoulder replacement surgery each year. Of these, it is reported that 0.4%-2.9% of anatomic total shoulder arthroplasties (aTSA) and 1-10% of reverse shoulder arthroplasties (rTSA) are complicated by periprosthetic joint infection (PJI).

Cutibacterium Acnes (C. acnes), an indolent organism found on the skin and in the sebaceous glands around the shoulder and back, makes the diagnosis of shoulder PJI particularly challenging. Multiple studies have shown that C. acnes can be isolated from deep cultures in up to 40% of patients without prior surgery undergoing primary total shoulder arthroplasty, although whether this indicates actual colonization of the joint or contamination is an area of debate.

A recent development in shoulder surgery is the use of hydrogen peroxide to decrease the C. acnes load in the deep dermis sebaceous glands, with the hope that this will prevent contamination of the joint during shoulder joint replacement surgery. Application of a widely commercially-available 3% topical Hydrogen peroxide in water solution in vitro has been found to completely eradicate C. acnes growth within 5 minutes and has been shown in clinical trials when used as part of the skin preparation to decrease the rate of positive cultures for C. acnes from 35% to 10% for deep cultures and from 34% to 17% for superficial dermal cultures. While these results show marked improvement compared to standard skin preparations, the 17% with positive dermal cultures is still concerning given the significant morbidity associated with a PJI.

Our hypothesis is that an additional application of hydrogen peroxide to the dermis itself, immediately following the skin incision, will be even more effective at eradicating this potential source of contamination deep in the joint.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32607
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Male patients, age 40-90
• Undergoing primary anatomic or reverse total shoulder arthroplasty for glenohumeral osteoarthritis or rotator cuff arthropathy

Exclusion Criteria:

• Female patients
• Patients under 40 years or over 90 years of age
• Diagnosis other than glenohumeral osteoarthritis or rotator cuff arthropathy
• Prior arthroscopic or open shoulder surgery on the ipsilateral shoulder
• Prior diagnosis of septic shoulder of the ipsilateral shoulder
• Corticosteroid injection within 3 months of the procedure
• Recently on antibiotics (within 2 weeks) prior to surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects getting 3% H2O2 applied to the incision; For the experimental cohort, a lap sponge soaked in 3% H2O2 will be applied to the incision and allowed to sit for 3 minutes. Following the 3 minutes, the sponge will be removed, the wound will be flushed with 100 mL of normal saline, and the exposed dermis will be swabbed and sent for culture.	Other: H2O2 application to incision; A lap sponge soaked in 3% H2O2 will be applied to the incision and allowed to sit for 3 minutes.
No Intervention: Subjects not getting 3% H2O2 applied to the incision; In the control cohort, the dermis will be swabbed and sent for culture immediately after the skin incision is made and the knife is removed from the field.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard 14-day OR hardware culture to measure the number of positive vs. negative cultures	Following our standard protocols for skin preparation (which includes an application of 3% H2O2, alcohol, and then Chloraprep in sequence) and draping (with Ioban applied over the skin), we will start the procedure as normal. The skin incision will be made in standard fashion, and the knife used will be removed from the surgical field. For the experimental cohort, a lap sponge soaked in 3% H2O2 will be applied to the incision and allowed to sit for 3 minutes. Following the 3 minutes, the sponge will be removed, the wound will be flushed with 100 mL of normal saline, and the exposed dermis will be swabbed and sent for culture. In the control cohort, the dermis will be swabbed and sent for culture immediately after the skin incision is made and the knife is removed from the field.	3 minutes prior to surgery

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Thomas Wright, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound; Anti-Infective Agents, Local; Anti-Infective Agents; Hydrogen Peroxide
• Other Study ID Numbers: IRB202002655; OCR39759 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes