Post-operative Surgical Site Infections
Conditions
Keywords
Surgical site infections, Chlorhexidine, Shoulder surgery
Brief summary
We intend to determine how effective the use of a 2% Chlorhexidine Cloth is in terms of eliminating the bacterial load on patients undergoing shoulder surgery. We will be comparing the Chlorhexidine Cloths with a control group which will be performing an ordinary shower prior to surgery. At this time, it is standard of care to only take an ordinary shower the evening prior, and the morning of surgery.
Detailed description
The use of home preoperative chlorhexidine wash has been used in various surgical fields for the prevention of perioperative infections. However, it's use in shoulder surgery has not been published up to this point. The shoulder has a unique microbial flora due to the prevalence of Propionibacterium acnes, a bacteria implicated in surgical site infections after shoulder surgery. This study is designed to examine the efficacy of using a preoperative Sage 2% chlorhexidine cloth in reducing bacterial load in the pre-operative area as well as in reducing post-operative surgical site infections after shoulder surgery. This study will compare the rate of post-operative infections and also the rate of positive skin cultures. The skin cultures will be obtained in the preoperative area from subjects who used the Sage 2% Chlorhexidine cloth protocol pre-operatively (n=50) versus those who used only soap and water (n=50).
Interventions
DRUG2% Chlorhexidine cloth
The 2% Chlorhexidine cloth will be applied to the operative extremity the night prior and the the morning of their surgery.
Sponsors
Sage Products, Inc.
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patient undergoing shoulder surgery (open or arthroscopic)
Exclusion criteria
* Patient unwilling to comply with instructions * Active infection in the operative extremity * Documented allergic reaction to chlorhexidine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients With a Clinically Diagnosed Infection | 2 months post-operatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery | 7 days | Rate of positive cultures from entire shoulder region (combined from axilla and posterior shoulder) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date. | 50 |
| 2% Chlorhexidine Cloth This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | 2% Chlorhexidine Cloth | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 4 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 46 Participants | 89 Participants |
| Age, Continuous | 49.0 years STANDARD_DEVIATION 9 | 52.0 years STANDARD_DEVIATION 8 | 50.5 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 36 Participants | 25 Participants | 61 Participants |
| Sex: Female, Male Male | 14 Participants | 25 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Number of Patients With a Clinically Diagnosed Infection
Time frame: 2 months post-operatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Number of Patients With a Clinically Diagnosed Infection | 0 participants |
| Chlorhexidine | Number of Patients With a Clinically Diagnosed Infection | 0 participants |
Secondary
Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery
Rate of positive cultures from entire shoulder region (combined from axilla and posterior shoulder)
Time frame: 7 days
Population: Rate of positive cultures from entire shoulder region (combined from axilla and posterior shoulder)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery | 94 percentage of participants |
| Chlorhexidine | Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery | 66 percentage of participants |