Surgical Site Infection
Conditions
Keywords
Propionibacterium Acnes, Surgical Site Infection, Shoulder
Brief summary
This study is about preventing surgical site infections of the shoulder. We hope to learn if clindamycin alone, benzoyl peroxide alone, or clindamycin and benzoyl peroxide together can affect growth of Propionibacterium acnes in the dermal layer.
Detailed description
P. acnes are skin pathogens known to cause surgical site infections despite proper preoperative surgical preparation. Lee et al. showed 70% growth rate of P. acnes despite the application of Choraprep prior to sampling. However, this study was limited as it failed to utilize a control group and only investigated one preparatory technique. Meanwhile, there remains to date no study investigating the effect of topical treatments. The purpose of this study is to investigate how specific topical treatments affect growth in the dermal layer. 12 volunteers who are normal volunteers, students, or employees of USC will each receive 4 punch biopsies from their back above the scapular spine, with each biopsy taken from a region of the skin treated with a different topical (topical clindamycin alone, topical benzoyl peroxide alone, topical clindamycin and benzoyl peroxide together, and a control). A 3df overall test of the treatment indicators will test for any differences in positivity for P Acnes among the treatments; pairwise comparisons among the treatments will adjust for multiple comparisons. A two-tailed statistical test will be performed, testing at an alpha of 0.05, and analyses will also be performed based on hemolytic subtypes.
Interventions
topical clindamycin
topical benzoyl peroxide
DRUGBenzaClin 5%-1% Topical Gel
Topical clindamycin and benzoyl peroxide together
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Healthy volunteers
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* healthy volunteer * age \> 18
Exclusion criteria
* history of antibiotic use in the last month * active acne on the back * non-English speakers (the study personnel do not have adequate training to converse and consent in other languages)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms | 21 days | Detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL) by treatment arms. |
Countries
United States
Participant flow
Pre-assignment details
All 12 patients received each of the 4 study arms.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants 1. Negative Control
2. Topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel
3. Topical clindamycin alone using Clindamycin 1% Gel
4. BenzaClin 5%-1% Topical Gel: Topical clindamycin and benzoyl peroxide together | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 12 Participants | — |
| Age, Continuous | 29.4 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 12 participants | — |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms
Detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL) by treatment arms.
Time frame: 21 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Negative Control | Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms | 10 participants |
| Benzoyl Peroxide 5% Topical Gel | Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms | 12 participants |
| Clindamycin 1% Topical Gel | Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms | 10 participants |
| Clindamycin 1% Plus Benzoyl Peroxide 5% Topical Gel | Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms | 10 participants |