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

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ClinicalTrials.gov Identifier: NCT04609306
Recruitment Status : Recruiting
First Posted : October 30, 2020
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary Anatomic or Reverse Total Shoulder Arthroplasty Other: H2O2 application to incision Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two group parallel study
Masking: Single (Participant)
Masking Description: Subjects will then be randomized 1:1 into Experimental or Control cohorts.
Primary Purpose: Treatment
Official Title: How Does Hydrogen Peroxide Application to the Wound Following Surgical Incision Affect C. Acnes Cultures in Primary Shoulder Arthroplasty?
Actual Study Start Date : January 26, 2021
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Standard 14-day OR hardware culture to measure the number of positive vs. negative cultures [ Time Frame: 3 minutes prior to surgery ]
    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.



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male patients
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04609306


Contacts
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Contact: Aimee Struk, MEd 352-273-7419 strukam@ortho.ufl.edu
Contact: Thomas Wright, MD 352-273-7375 wrightw@ortho.ufl.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32607
Contact: Aimee Struk    352-273-7419    strukam@ortho.ufl.edu   
Principal Investigator: Thomas Wright, MD         
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Thomas Wright, MD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04609306    
Other Study ID Numbers: IRB202002655
OCR39759 ( Other Identifier: UF OnCore )
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents