search
Back to results

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

Primary Purpose

Primary Anatomic or Reverse Total Shoulder Arthroplasty

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
H2O2 application to incision
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Anatomic or Reverse Total Shoulder Arthroplasty

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Subjects getting 3% H2O2 applied to the incision

Subjects not getting 3% H2O2 applied to the incision

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 22, 2020
Last Updated
November 2, 2022
Sponsor
University of Florida
search

1. Study Identification

Unique Protocol Identification Number
NCT04609306
Brief Title
Hydrogen Peroxide to the Wound Following Surgical Incision Affecting Cultures in Primary Shoulder Arthroplast
Official Title
How Does Hydrogen Peroxide Application to the Wound Following Surgical Incision Affect C. Acnes Cultures in Primary Shoulder Arthroplasty?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 26, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Anatomic or Reverse Total Shoulder Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two group parallel study
Masking
Participant
Masking Description
Subjects will then be randomized 1:1 into Experimental or Control cohorts.
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects getting 3% H2O2 applied to the incision
Arm Type
Experimental
Arm Description
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.
Arm Title
Subjects not getting 3% H2O2 applied to the incision
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
H2O2 application to incision
Intervention Description
A lap sponge soaked in 3% H2O2 will be applied to the incision and allowed to sit for 3 minutes.
Primary Outcome Measure Information:
Title
Standard 14-day OR hardware culture to measure the number of positive vs. negative cultures
Description
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.
Time Frame
3 minutes prior to surgery

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male patients
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Wright, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs