Hydrogen Peroxide to the Wound Following Surgical Incision Affecting Cultures in Primary Shoulder Arthroplast
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04609306|
Recruitment Status : Recruiting
First Posted : October 30, 2020
Last Update Posted : March 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Primary Anatomic or Reverse Total Shoulder Arthroplasty||Other: H2O2 application to incision||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two group parallel study|
|Masking Description:||Subjects will then be randomized 1:1 into Experimental or Control cohorts.|
|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|
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.
- 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.
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
|Contact: Aimee Struk, MEdfirstname.lastname@example.org|
|Contact: Thomas Wright, MDemail@example.com|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32607|
|Contact: Aimee Struk 352-273-7419 firstname.lastname@example.org|
|Principal Investigator: Thomas Wright, MD|
|Principal Investigator:||Thomas Wright, MD||University of Florida|