Surgical Site Infection
Conditions
Brief summary
This study will evaluate a new topical skin antiseptic perioperative preparation and the standard of care to determine efficacy on the rates of surgical site infections of surgical patients. Safety will also be assessed.
Interventions
DRUG70% v/v Isopropyl Alcohol Surgical Solution
Patient preoperative skin preparation
DRUG2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol
Patient preoperative skin preparation
Sponsors
Zurex Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Be male or female and at least 18 years of age. 2. Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English. 3. Be planning to undergo clean (class I wound) or clean-contaminated (class II wounds) surgery. 4. Expect to be available for up to 30-days after the surgery.
Exclusion criteria
1. Active infection or fever including evidence of infection at or adjacent to the operative site. 2. Immunosuppressed. 3. Kidney/liver failure. 4. Immunosuppressive therapy (chemotherapy, steroids) within the previous 1 week. 5. Any history of allergy to chlorhexidine or isopropyl alcohol or any other component in ZuraGard including citric acid, sodium citrate, methylparaben, or propylparaben, and FD&C Yellow #6.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infection Occurrence | Within 30 days after surgery | The primary objective is to demonstrate efficacy in surgical use through the rate of surgical site infections. |
| Allergic Reaction and Skin Irritation | Within 30 days after surgery | The primary safety objective is to determine the rates of skin irritation or allergic reactions attributed to each drug product and all other adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subgroup Analysis of Rates of Surgical Site Infections | Within 30 days after surgery | Surgical site infection rates by different infection types classified as superficial incisional infection, deep incisional infection, or organ-space infection. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic 70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation
70% v/v Isopropyl Alcohol Surgical Solution: Patient preoperative skin preparation | 25 |
| 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation
2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol: Patient preoperative skin preparation | 26 |
| Total | 51 |
Baseline characteristics
| Characteristic | 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 14 Participants | 15 Participants | 29 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 11 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 26 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 25 Participants | 50 Participants |
| Region of Enrollment United States | 25 Participants | 26 Participants | 51 Participants |
| Sex: Female, Male Female | 15 Participants | 11 Participants | 26 Participants |
| Sex: Female, Male Male | 10 Participants | 15 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 1 / 26 |
| other Total, other adverse events | 0 / 25 | 0 / 26 |
| serious Total, serious adverse events | 10 / 25 | 11 / 26 |
Outcome results
Primary
Allergic Reaction and Skin Irritation
The primary safety objective is to determine the rates of skin irritation or allergic reactions attributed to each drug product and all other adverse events.
Time frame: Within 30 days after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | Allergic Reaction and Skin Irritation | 1 Participants |
| 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | Allergic Reaction and Skin Irritation | 1 Participants |
Primary
Surgical Site Infection Occurrence
The primary objective is to demonstrate efficacy in surgical use through the rate of surgical site infections.
Time frame: Within 30 days after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | Surgical Site Infection Occurrence | 0 Participants |
| 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | Surgical Site Infection Occurrence | 1 Participants |
Secondary
Subgroup Analysis of Rates of Surgical Site Infections
Surgical site infection rates by different infection types classified as superficial incisional infection, deep incisional infection, or organ-space infection.
Time frame: Within 30 days after surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | Subgroup Analysis of Rates of Surgical Site Infections | superficial incisional infection | 0 Participants |
| 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | Subgroup Analysis of Rates of Surgical Site Infections | deep incisional infection | 0 Participants |
| 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | Subgroup Analysis of Rates of Surgical Site Infections | organ-space infection | 0 Participants |
| 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | Subgroup Analysis of Rates of Surgical Site Infections | No surgical site infection present | 25 Participants |
| 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | Subgroup Analysis of Rates of Surgical Site Infections | No surgical site infection present | 25 Participants |
| 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | Subgroup Analysis of Rates of Surgical Site Infections | superficial incisional infection | 0 Participants |
| 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | Subgroup Analysis of Rates of Surgical Site Infections | organ-space infection | 0 Participants |
| 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | Subgroup Analysis of Rates of Surgical Site Infections | deep incisional infection | 1 Participants |
Secondary
Subgroup Analysis of Rates of Surgical Site Infections
Surgical site infection rates by type of surgery including clean (class I wound) or clean-contaminated (class II wounds) surgeries
Time frame: Within 30 days after surgery
Population: Secondary outcome categorizes the results of the primary outcome - surgical site infections. The study only resulted in observation of 1 surgical site infection in one of the two interventions. Therefore, the novel prep secondary outcome results in a zero value reported.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | Subgroup Analysis of Rates of Surgical Site Infections | Class I - Clean | 0 Participants |
| 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | Subgroup Analysis of Rates of Surgical Site Infections | Class II - Clean-Contaminated | 0 Participants |
| 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | Subgroup Analysis of Rates of Surgical Site Infections | Class I - Clean | 1 Participants |
| 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | Subgroup Analysis of Rates of Surgical Site Infections | Class II - Clean-Contaminated | 0 Participants |