Methicillin-Resistant Staphylococcus Aureus, Preoperative Care, Surgical Wound Infection
Conditions
Brief summary
To evaluate the efficacy and tolerability of 10% povidone-iodine in eliminating nasal carriage of Staphylococcus aureus and MRSA. To determine whether a more convenient, single-dose, pre-operative 10% povidone-iodine (PI) application is effective in reducing nasal carriage of S. aureus and MRSA. We expect a statistically significant decrease in S. aureus/MRSA colonization in nasal cultures taken perioperatively after intervention in patients who received pretreatment with PI as compared to patients who received normal saline (NS).
Detailed description
This will be a prospective single-blinded randomized placebo-controlled trial of two applications of a nasal 10% Povidone Iodine (PI) solution used on the intranasal mucosal surfaces of each nostril in the preoperative holding area within 2 h prior to surgical incision compared with NS using the same technique. Both the PI and NS will be applied by rotating the swab over the intranasal mucosal surface for 15 seconds; this process will be performed twice for both nostrils, using a new swab for each application. Nasal cultures will be obtained prior to PI or NS application as well as intraoperatively 1 hour and 2 hours after first surgical incision. The primary study end point is the decrease in S. aureus/MRSA colony forming units (CFU) in nasal cultures taken within 2 hours after intervention in patients who presented with a positive preintervention nasal culture. A secondary endpoint is the presence or absence of surgical site infections within 30 days postoperatively
Interventions
Nasal swab stick application of Povidone-Iodine 10% prior to surgery
Nasal swab stick application of 0.9% NaCl Solution prior to surgery
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Patients are assigned to treatment group or placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* community-based patients ages 18-80 * American Society of Anesthesiology (ASA) 1-3 * undergoing an outpatient surgery for at least 1 hour and up to 6 hours duration
Exclusion criteria
* pregnancy * allergy to povidone-iodine * infectious indication for surgery or preexisting known infection/wound * immunocompromised state * use of chemotherapy or steroids within 30 days prior to surgery * use of antimicrobial therapy within 30 days prior to surgery * surgeries where field avoidance prevents intraoperative access to the nares
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in S. Aureus/MRSA Colony Forming Units (CFU) in Nasal Swab Specimen After Treatment in Patients Who Presented With a Positive for S. Aureus/MRSA Pre-interventional Nasal Swab Specimen. | 1, 2, and 3 hours after application of Povidone-Iodine or saline solution | The difference in a number of S. aureus/MRSA CFU in nasal swab specimens between before and after the study drug/placebo application in patients with a positive for S. aureus/MRSA pre-interventional nasal swab specimen. The change (Δ) is calculated as the value at the baseline time point minus the value at the later time point. Positive values represent a decrease in CFU, whereas negative values represent an increase in CFU. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infections | at 7 and 30-day postoperative intervals | The presence of surgical site infections |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Application of Povidone-Iodine 10% prior to surgery to Nares
Povidone-Iodine 10%: Nasal swab stick application of Povidone-Iodine 10% prior to surgery | 95 |
| Treatment Application of Povidone-Iodine 10% prior to surgery to Nares
Povidone-Iodine 10%: Nasal swab stick application of Povidone-Iodine 10% prior to surgery | 88 |
| Placebo Application of 0.9% Sodium Chloride (NaCl) solution prior to surgery to Nares
0.9% NaCl Solution: Nasal swab stick application of 0.9% NaCl Solution prior to surgery | 97 |
| Placebo Application of 0.9% Sodium Chloride (NaCl) solution prior to surgery to Nares
0.9% NaCl Solution: Nasal swab stick application of 0.9% NaCl Solution prior to surgery | 91 |
| Total | 371 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 3 | 6 |
| Overall Study | Sample shipment delay more than one day | 4 | 0 |
Baseline characteristics
| Characteristic | Placebo | Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 7 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 86 Participants | 88 Participants | 174 Participants |
| Age, Continuous | 47.27 years STANDARD_DEVIATION 14.84 | 44.86 years STANDARD_DEVIATION 14.97 | 46.08 years STANDARD_DEVIATION 14.92 |
| Number of S. aureus/ MRSA colony-forming unit (CFU) per Sample Number of MRSA CFU per Sample | 25 CFU per sample | 125.5 CFU per sample | 51.8 CFU per sample |
| Number of S. aureus/ MRSA colony-forming unit (CFU) per Sample Number of S. aureus CFU per Sample | 2500 CFU per sample | 2500 CFU per sample | 2500 CFU per sample |
| Race/Ethnicity, Customized Asian | 4 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 46 Participants | 38 Participants | 84 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 31 Participants | 37 Participants | 68 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 13 Participants | 12 Participants | 25 Participants |
| Sex/Gender, Customized Female | 51 Participants | 49 Participants | 100 Participants |
| Sex/Gender, Customized Male | 45 Participants | 44 Participants | 89 Participants |
| Sex/Gender, Customized Prefer not to identify | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Unknown | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 95 | 0 / 97 |
| other Total, other adverse events | 2 / 95 | 0 / 97 |
| serious Total, serious adverse events | 0 / 95 | 0 / 97 |
Outcome results
Primary
Change in S. Aureus/MRSA Colony Forming Units (CFU) in Nasal Swab Specimen After Treatment in Patients Who Presented With a Positive for S. Aureus/MRSA Pre-interventional Nasal Swab Specimen.
The difference in a number of S. aureus/MRSA CFU in nasal swab specimens between before and after the study drug/placebo application in patients with a positive for S. aureus/MRSA pre-interventional nasal swab specimen. The change (Δ) is calculated as the value at the baseline time point minus the value at the later time point. Positive values represent a decrease in CFU, whereas negative values represent an increase in CFU.
Time frame: 1, 2, and 3 hours after application of Povidone-Iodine or saline solution
Population: Nasal samples (NS) taken from 42 participants out of 95 assigned to the treatment group, and 47 out of 97 assigned to the placebo group that tested positive for S. aureus before the intervention were analyzed at every following time point: 1, 2, and 3 hours after the intervention (AI).~NS taken from 32 participants out of 95 assigned to the treatment group, and 35 out of 97 assigned to the placebo group were positive for MRSA at baseline and were analyzed for MRSA at 1,2, and 3 hours AI.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment | Change in S. Aureus/MRSA Colony Forming Units (CFU) in Nasal Swab Specimen After Treatment in Patients Who Presented With a Positive for S. Aureus/MRSA Pre-interventional Nasal Swab Specimen. | The difference in a number of MRSA CFU between before and 3 hours after drug application | 2904.8 CFU per sample (∆) |
| Treatment | Change in S. Aureus/MRSA Colony Forming Units (CFU) in Nasal Swab Specimen After Treatment in Patients Who Presented With a Positive for S. Aureus/MRSA Pre-interventional Nasal Swab Specimen. | The difference in a number of MRSA CFU between before and 1 hour after drug application | 2904.8 CFU per sample (∆) |
| Treatment | Change in S. Aureus/MRSA Colony Forming Units (CFU) in Nasal Swab Specimen After Treatment in Patients Who Presented With a Positive for S. Aureus/MRSA Pre-interventional Nasal Swab Specimen. | The difference in a number of S. aureus CFU between before and 1 hour after drug application | 12062.5 CFU per sample (∆) |
| Treatment | Change in S. Aureus/MRSA Colony Forming Units (CFU) in Nasal Swab Specimen After Treatment in Patients Who Presented With a Positive for S. Aureus/MRSA Pre-interventional Nasal Swab Specimen. | The difference in a number of MRSA CFU between before and 2 hours after drug application | 2457 CFU per sample (∆) |
| Treatment | Change in S. Aureus/MRSA Colony Forming Units (CFU) in Nasal Swab Specimen After Treatment in Patients Who Presented With a Positive for S. Aureus/MRSA Pre-interventional Nasal Swab Specimen. | The difference in a number of S. aureus CFU between before and 3 hours after drug application | 12497 CFU per sample (∆) |
| Treatment | Change in S. Aureus/MRSA Colony Forming Units (CFU) in Nasal Swab Specimen After Treatment in Patients Who Presented With a Positive for S. Aureus/MRSA Pre-interventional Nasal Swab Specimen. | The difference in a number of S. aureus CFU between before and 2 hours after drug applicatia | 12525 CFU per sample (∆) |
| Placebo | Change in S. Aureus/MRSA Colony Forming Units (CFU) in Nasal Swab Specimen After Treatment in Patients Who Presented With a Positive for S. Aureus/MRSA Pre-interventional Nasal Swab Specimen. | The difference in a number of MRSA CFU between before and 3 hours after drug application | 360 CFU per sample (∆) |
| Placebo | Change in S. Aureus/MRSA Colony Forming Units (CFU) in Nasal Swab Specimen After Treatment in Patients Who Presented With a Positive for S. Aureus/MRSA Pre-interventional Nasal Swab Specimen. | The difference in a number of S. aureus CFU between before and 1 hour after drug application | 737 CFU per sample (∆) |
| Placebo | Change in S. Aureus/MRSA Colony Forming Units (CFU) in Nasal Swab Specimen After Treatment in Patients Who Presented With a Positive for S. Aureus/MRSA Pre-interventional Nasal Swab Specimen. | The difference in a number of S. aureus CFU between before and 2 hours after drug applicatia | 711.2 CFU per sample (∆) |
| Placebo | Change in S. Aureus/MRSA Colony Forming Units (CFU) in Nasal Swab Specimen After Treatment in Patients Who Presented With a Positive for S. Aureus/MRSA Pre-interventional Nasal Swab Specimen. | The difference in a number of S. aureus CFU between before and 3 hours after drug application | 4160 CFU per sample (∆) |
| Placebo | Change in S. Aureus/MRSA Colony Forming Units (CFU) in Nasal Swab Specimen After Treatment in Patients Who Presented With a Positive for S. Aureus/MRSA Pre-interventional Nasal Swab Specimen. | The difference in a number of MRSA CFU between before and 1 hour after drug application | 360 CFU per sample (∆) |
| Placebo | Change in S. Aureus/MRSA Colony Forming Units (CFU) in Nasal Swab Specimen After Treatment in Patients Who Presented With a Positive for S. Aureus/MRSA Pre-interventional Nasal Swab Specimen. | The difference in a number of MRSA CFU between before and 2 hours after drug application | 412 CFU per sample (∆) |
p-value: <0.05Wilcoxon (Mann-Whitney)
Secondary
Surgical Site Infections
The presence of surgical site infections
Time frame: at 7 and 30-day postoperative intervals
Population: Row population differs from the overall as the secondary outcome was analyzed for 88 out of 95 participants assigned to the treatment group and 91 out of 97 to the placebo group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment | Surgical Site Infections | Confirmed surgical site infection in the first 7 days postoperatively | 0 Participants |
| Treatment | Surgical Site Infections | Confirmed surgical site infection up to 30±4 days postoperatively | 1 Participants |
| Placebo | Surgical Site Infections | Confirmed surgical site infection in the first 7 days postoperatively | 1 Participants |
| Placebo | Surgical Site Infections | Confirmed surgical site infection up to 30±4 days postoperatively | 6 Participants |