Primary Anatomic or Reverse Total Shoulder ArthroplastyNCT04609306
Hydrogen Peroxide to the Wound Following Surgical Incision Affecting Cultures in Primary Shoulder Arthroplast
A study testing H2O2 application to incision in people with Primary Anatomic or Reverse Total Shoulder Arthroplasty, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- Primary Anatomic or Reverse Total Shoulder Arthroplasty
- What is being tested?
- H2O2 application to incision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2021to 7 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients, age 40-90
- Undergoing primary anatomic or reverse total shoulder arthroplasty for glenohumeral osteoarthritis or rotator cuff arthropathy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- H2O2 application to incision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H2O2 application to incisionOther
A lap sponge soaked in 3% H2O2 will be applied to the incision and allowed to sit for 3 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Subjects getting 3% H2O2 applied to the incision | Experimental | 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. Receives: Other: H2O2 application to incision |
| Subjects not getting 3% H2O2 applied to the incision | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Number of Positive vs Negative Culture's Based on Skin Prep Method
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.
Measured: 3 minutes prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start26 Jan 2021
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Anatomic or Reverse Total Shoulder ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group parallel study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Wright, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609306
- Sponsor's protocol ID
- IRB202002655
- Other IDs
- OCR39759
- Status last verified
- Jun 2024
- First submitted
- 22 Oct 2020
- Last updated
- 22 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Hydrogen Peroxide Application to the Wound Following Surgical Incision Affect C. Acnes Cultures in Primary Shoulder Arthroplasty?
- ClinicalTrials.gov ID
- NCT04609306
- Acronym / sponsor ID
- IRB202002655
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Posted 22 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two group parallel study
| Arm | Type | Receives |
|---|---|---|
| Subjects getting 3% H2O2 applied to the incision | Experimental | Other: H2O2 application to incisionFor 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. |
| Subjects not getting 3% H2O2 applied to the incision | No intervention | –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. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male patients, age 40-90
- Undergoing primary anatomic or reverse total shoulder arthroplasty for glenohumeral osteoarthritis or rotator cuff arthropathy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H2O2 application to incisionA lap sponge soaked in 3% H2O2 will be applied to the incision and allowed to sit for 3 minutes. | Other | Subjects getting 3% H2O2 applied to the incision |
Primary outcome
Number of Positive vs Negative Culture's Based on Skin Prep Method
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Wright, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H2O2 application to incision in people with Primary Anatomic or Reverse Total Shoulder Arthroplasty, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Positive vs Negative Culture's Based on Skin Prep Method (time frame: 3 minutes prior to surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.