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Skin Prep to Reduce Postoperative Shoulder Infection

Adjusting Skin Prep to Decrease Risk of P. Acnes Related Shoulder Infection

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02510144
Enrollment
80
Registered
2015-07-29
Start date
2015-08-31
Completion date
2018-07-31
Last updated
2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Infection

Brief 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. 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.

Interventions

DRUGSkin Prep Chlorhexidine

3 day preoperative skin prep prior to surgery

DRUGSkin Prep Benzoyl Peroxide

3 day preoperative skin prep prior to surgery

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \>18 * Indicated for shoulder surgery

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Skin Swab and Culture With Colony Forming Units (CFUs)At time of surgeryPreoperative 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.

Secondary

MeasureTime frameDescription
Surgical Site Infection That Requires AntibioticsAt one yearCultures were evaluated in our lab and also tested for hemolysis as a possible indicator of a more virulent strain in the literature.

Countries

United States

Participant flow

Participants by arm

ArmCount
Chlorhexidine
A preoperative Chlorhexidine gluconate solution 4.0% (i.e Hibiclens) Skin Prep Chlorhexidine: 3 day preoperative skin prep prior to surgery
39
Benzoyl Peroxide
A preoperative 5% benzoyl peroxide wash prep (i.e. Brevoxyl-4 and Brevoxyl-8) Skin Prep Benzoyl Peroxide: 3 day preoperative skin prep prior to surgery
41
Total80

Baseline characteristics

CharacteristicChlorhexidineTotalBenzoyl Peroxide
Active smokers10 Participants23 Participants13 Participants
Age, Continuous51 years51 years51 years
Arthroplasty cases14 Participants27 Participants13 Participants
BMI30.2 kg/m^230.5 kg/m^230.7 kg/m^2
Diabetes8 Participants16 Participants8 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
39 participants80 participants41 participants
Sex: Female, Male
Female
20 Participants43 Participants23 Participants
Sex: Female, Male
Male
19 Participants37 Participants18 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 390 / 41
other
Total, other adverse events
0 / 390 / 41
serious
Total, serious adverse events
0 / 390 / 41

Outcome results

Primary

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.

Time frame: At time of surgery

Population: 8 samples/skin cultures were obtained from each participant; 4 from each shoulder. The contralateral shoulder was the control.

ArmMeasureGroupValue (NUMBER)
ChlorhexidineSkin Swab and Culture With Colony Forming Units (CFUs)Intervention39 negative skin cultures
ChlorhexidineSkin Swab and Culture With Colony Forming Units (CFUs)Control35 negative skin cultures
Benzoyl PeroxideSkin Swab and Culture With Colony Forming Units (CFUs)Intervention51 negative skin cultures
Benzoyl PeroxideSkin Swab and Culture With Colony Forming Units (CFUs)Control22 negative skin cultures
Comparison: Negative cultures were compared on the treated side vs the non-treated sidep-value: 0.68t-test, 2 sided
Comparison: Negative cultures were compared on the treated side versus the non-treated sidep-value: <0.01t-test, 2 sided
Secondary

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.

Time frame: At one year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ChlorhexidineSurgical Site Infection That Requires Antibiotics0 Participants
Benzoyl PeroxideSurgical Site Infection That Requires Antibiotics0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026