Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine | Active Comparator | A preoperative Chlorhexidine gluconate solution 4.0% (i.e Hibiclens) |
|
| Benzoyl Peroxide | Experimental | A preoperative 5% benzoyl peroxide wash prep (i.e. Brevoxyl-4 and Brevoxyl-8) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin Prep Chlorhexidine | Drug | 3 day preoperative skin prep prior to surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At one year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Midtown Hospital | Baltimore | Maryland | 21201 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Chlorhexidine | A preoperative Chlorhexidine gluconate solution 4.0% (i.e Hibiclens) Skin Prep Chlorhexidine: 3 day preoperative skin prep prior to surgery |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Chlorhexidine | A preoperative Chlorhexidine gluconate solution 4.0% (i.e Hibiclens) Skin Prep Chlorhexidine: 3 day preoperative skin prep prior to surgery |
| BG001 | Benzoyl Peroxide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 8 samples/skin cultures were obtained from each participant; 4 from each shoulder. The contralateral shoulder was the control. | Posted | Number | negative skin cultures | At time of surgery | skin cultures | skin cultures |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chlorhexidine | A preoperative Chlorhexidine gluconate solution 4.0% (i.e Hibiclens) Skin Prep Chlorhexidine: 3 day preoperative skin prep prior to surgery |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mohit Gilotra | University of Maryland Baltimore | (301) 502-4102 | mgilotra@som.umaryland.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2015 | Nov 26, 2019 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
| Skin Prep Benzoyl Peroxide |
| Drug |
3 day preoperative skin prep prior to surgery |
|
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Full Range | kg/m^2 |
|
| Active smokers | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Arthroplasty cases | Count of Participants | Participants |
|
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
|
|
|
| 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. | Posted | Count of Participants | Participants | At one year |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | 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 | 0 | 41 | 0 | 41 | 0 | 41 |
Not provided
Not provided
Not provided