Shoulder InfectionNCT02510144
Skin Prep to Reduce Postoperative Shoulder Infection
A study testing Skin Prep Chlorhexidine and Skin Prep Benzoyl Peroxide in people with Shoulder Infection, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Propionibacterium acnes is the most common pathogen identified from a surgical site infection in the shoulder. Standard skin preps do not prevent this type of infection. Patients will undergo either a chlorhexidine or benzoyl peroxide prep in days leading up to surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Infection
- What is being tested?
- Skin Prep Chlorhexidine and Skin Prep Benzoyl Peroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jul 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18
- Indicated for shoulder surgery
Who cannot join
- History of previous shoulder infection
- Allergy to Chlorhexidine or benzoyl peroxide
- Current use of anti-acne medicine around the shoulder
- Patient is pregnant or concerned about pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Midtown Hospital
Baltimore, Maryland, 21201
About this study
Official title: Adjusting Skin Prep to Decrease Risk of P. Acnes Related Shoulder Infection
Propionibacterium acnes is the most common pathogen identified from a surgical site infection in the shoulder. Standard skin preps do not prevent this type of infection. Patients will undergo either a chlorhexidine or benzoyl peroxide prep in days leading up to surgery. Bacterial burden will be determined at the time of surgery.
Read the detailed description
After surgical posting, patients will be randomized to chlorhexidine or benzoyl peroxide group. The solutions used will be 5% benzoyl peroxide emollient foam and 4% chlorhexidine gluconate skin cleanser. Participants will be instructed to conduct skin wash using the appropriate solution in the shower over the operative shoulder and axilla for three mornings prior to surgery (pre op day -2, pre op day -1, and morning of surgery). Specific instructions will include leaving the solution on the skin for three minutes and avoiding contact with eyes, ears, and mouth. Proper technique will be demonstrated at time of patient recruitment and given as a handout with the wash solution provided. A reminder phone call will occur two days before surgery to remind patients of proper procedure to improve compliance. On the day of surgery, patients be interviewed about pre-operative compliance.
On the day of surgery, two cultures will be taken in three separate sites on both shoulders (anterior, lateral, and posterior) using a detergent scrub technique, the current dermatologic standard for biopsy of the deep sebaceous glands. (3,11) This procedure is typically performed on the skin of awake patients and causes minimal pain and skin irritation. Cultures will be evaluated in our lab. We will also test for hemolysis as a possible indicator of a more virulent strain in the literature.
The research team may take photos of the shoulder skin being swabbed. Photos will not include the facial or defining characteristics. Photos may be taken either in the clinic at time of recruitment or in the operating room when samples are being taken.
Inclusion criteria: all patients undergoing open shoulder surgery or shoulder arthroscopy. Exclusion criteria: anyone with a history of allergic reaction to chlorhexidine or benzoyl peroxide. Anyone with a history of previous shoulder infection, current open skin lesions around the shoulder or the use of current anti-acne medications around the shoulder.
Healthy volunteer portion: Healthy volunteers will respond to the study from fliers on campus. A cotton swab test on both shoulders will be performed prior to any treatment. If a threshold of P. Acnes is met (>1000 Colony Forming Units (CFUs)) then volunteers will be randomized to the same two groups and retested after three days of unilateral treatment. Finally, volunteers will undergo repeat cotton swab testing one week after 3 day wash was finalized.
- Conditions
- Shoulder Infection
- Being tested
- Skin Prep Chlorhexidine, Skin Prep Benzoyl Peroxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Prep ChlorhexidineDrug
3 day preoperative skin prep prior to surgery
Skin Prep Benzoyl PeroxideDrug
3 day preoperative skin prep prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine | Active comparator | A preoperative Chlorhexidine gluconate solution 4.0% (i.e Hibiclens) Receives: Drug: Skin Prep Chlorhexidine |
| Benzoyl Peroxide | Experimental | A preoperative 5% benzoyl peroxide wash prep (i.e. Brevoxyl-4 and Brevoxyl-8) Receives: Drug: Skin Prep Benzoyl Peroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Swab and Culture With Colony Forming Units (CFUs)
Preoperative Cutibacterium acnes shoulder burden. Skin cultures of both shoulders were obtained via a detergent scrub technique the day of surgery at anterior, lateral, and posterior sites and the axilla.
Measured: At time of surgery
Secondary outcomes (1)
Surgical Site Infection That Requires Antibiotics
Cultures were evaluated in our lab and also tested for hemolysis as a possible indicator of a more virulent strain in the literature.
Measured: At one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2018
- Study completionJul 2018
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 Shoulder InfectionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohit N. Gilotra, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510144
- Sponsor's protocol ID
- HP-00064296
- Status last verified
- Jan 2020
- First submitted
- 23 Jul 2015
- Last updated
- 11 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjusting Skin Prep to Decrease Risk of P. Acnes Related Shoulder Infection
- ClinicalTrials.gov ID
- NCT02510144
- Acronym / sponsor ID
- HP-00064296
- Conditions
- Shoulder Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 29 Jul 2015 (estimated)
- Results
- Posted 29 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Propionibacterium acnes is the most common pathogen identified from a surgical site infection in the shoulder. Standard skin preps do not prevent this type of infection. Patients will undergo either a chlorhexidine or benzoyl peroxide prep in days leading up to surgery. Bacterial burden will be determined at the time of surgery.
Detailed description
After surgical posting, patients will be randomized to chlorhexidine or benzoyl peroxide group. The solutions used will be 5% benzoyl peroxide emollient foam and 4% chlorhexidine gluconate skin cleanser. Participants will be instructed to conduct skin wash using the appropriate solution in the shower over the operative shoulder and axilla for three mornings prior to surgery (pre op day -2, pre op day -1, and morning of surgery). Specific instructions will include leaving the solution on the skin for three minutes and avoiding contact with eyes, ears, and mouth. Proper technique will be demonstrated at time of patient recruitment and given as a handout with the wash solution provided. A reminder phone call will occur two days before surgery to remind patients of proper procedure to improve compliance. On the day of surgery, patients be interviewed about pre-operative compliance.
On the day of surgery, two cultures will be taken in three separate sites on both shoulders (anterior, lateral, and posterior) using a detergent scrub technique, the current dermatologic standard for biopsy of the deep sebaceous glands. (3,11) This procedure is typically performed on the skin of awake patients and causes minimal pain and skin irritation. Cultures will be evaluated in our lab. We will also test for hemolysis as a possible indicator of a more virulent strain in the literature.
The research team may take photos of the shoulder skin being swabbed. Photos will not include the facial or defining characteristics. Photos may be taken either in the clinic at time of recruitment or in the operating room when samples are being taken.
Inclusion criteria: all patients undergoing open shoulder surgery or shoulder arthroscopy. Exclusion criteria: anyone with a history of allergic reaction to chlorhexidine or benzoyl peroxide. Anyone with a history of previous shoulder infection, current open skin lesions around the shoulder or the use of current anti-acne medications around the shoulder.
Healthy volunteer portion: Healthy volunteers will respond to the study from fliers on campus. A cotton swab test on both shoulders will be performed prior to any treatment. If a threshold of P. Acnes is met (>1000 Colony Forming Units (CFUs)) then volunteers will be randomized to the same two groups and retested after three days of unilateral treatment. Finally, volunteers will undergo repeat cotton swab testing one week after 3 day wash was finalized.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine | Active comparator | Drug: Skin Prep ChlorhexidineA preoperative Chlorhexidine gluconate solution 4.0% (i.e Hibiclens) |
| Benzoyl Peroxide | Experimental | Drug: Skin Prep Benzoyl PeroxideA preoperative 5% benzoyl peroxide wash prep (i.e. Brevoxyl-4 and Brevoxyl-8) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18
- Indicated for shoulder surgery
Key exclusion criteria (4 listed)
- History of previous shoulder infection
- Allergy to Chlorhexidine or benzoyl peroxide
- Current use of anti-acne medicine around the shoulder
- Patient is pregnant or concerned about pregnancy
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 |
|---|---|---|
| Skin Prep Chlorhexidine3 day preoperative skin prep prior to surgery | Drug | Chlorhexidine |
| Skin Prep Benzoyl Peroxide3 day preoperative skin prep prior to surgery | Drug | Benzoyl Peroxide |
Primary outcome
Skin Swab and Culture With Colony Forming Units (CFUs)
Time frame: At time of surgery
Preoperative Cutibacterium acnes shoulder burden. Skin cultures of both shoulders were obtained via a detergent scrub technique the day of surgery at anterior, lateral, and posterior sites and the axilla.
1 secondary outcome
Surgical Site Infection That Requires Antibiotics
Time frame: At one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin Prep Chlorhexidine and Skin Prep Benzoyl Peroxide in people with Shoulder Infection, run by University of Maryland, Baltimore 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 4 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 11 Feb 2020. 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 29 Jan 2020). 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?
Skin Swab and Culture With Colony Forming Units (CFUs) (time frame: At time of 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 11 Feb 2020.