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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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Surgical site infections (SSI) are one of the most common complications in the post-operative patient, and the second most common health care associated infection overall. It is estimated that there are between 500 thousand and 1.1 million surgical site infections in the United States each year. Given the magnitude of the problem, prevention of surgical site infections is a major goal of peri-operative care. However, skin preparation prior to surgery has not been as rigorously examined. The primary objective of this study is to compare the efficacy of two FDA approved, popular peri-operative skin preparations 2% chlorhexidine gluconate / 70% isopropyl alcohol to Iodine Povacrylex [0.7% available Iodine] / 74% Isopropyl Alcohol in the prevention of superficial surgical site infection. Male and female patients, age 18 years and older undergoing elective colorectal surgical procedures involving a laparotomy will be enrolled. These patients are at high risk of SSI. Eligible patients will be assessed at regular intervals for SSI and characterization of bacterial pathogen(s) in patients with SSI. Patients will remain enrolled into the study until 35 days postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol | Active Comparator | Preoperative Skin Antisepsis Preparation |
|
| Iodine Povacrylex/74% Isopropyl Alcohol | Active Comparator | Preoperative Skin Antisepsis Preparation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol | Drug | Preoperative skin antisepsis preparation |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Objective Measures the Proportion of Patients With Superficial Site Infection as Defined by the CDC. | The primary objective compares the efficacy of 2% chlorhexidine gluconate / 70% isopropyl alcohol (ChloraPrep) to Iodine Povacrylex [0.7% available Iodine] / 74% Isopropyl Alcohol (DuraPrep) in the prevention of superficial surgical site infection. The primary objective will be measured by the number and percentage of patients with superficial site infection as defined by the CDC. | within 35 days of randomization to treatment assignment |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Develop Surgical Site Infection | average time from surgery to surgical site infection diagnosis | within 35 days of randomization to treatment assignment |
| Bacterial Pathogens Present in Documented Surgical Site Infection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Najjia N Mahmoud, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States | ||
| Penn Presbyterian Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28277409 | Derived | Broach RB, Paulson EC, Scott C, Mahmoud NN. Randomized Controlled Trial of Two Alcohol-based Preparations for Surgical Site Antisepsis in Colorectal Surgery. Ann Surg. 2017 Dec;266(6):946-951. doi: 10.1097/SLA.0000000000002189. | |
| 25322531 | Derived | Poulin P, Chapman K, McGahan L, Austen L, Schuler T. Preoperative skin antiseptics for preventing surgical site infections: what to do? ORNAC J. 2014 Sep;32(3):12-5, 24-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chlorhexidine-Alcohol | Preoperative Skin Antisepsis Preparation 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation |
| FG001 | Iodine Povacrylex-Alcohol | Preoperative Skin Antisepsis Preparation Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Chlorhexidine-Alcohol arm - 8 participants were excluded after treatment administered due to inclusion/exclusion criteria
Iodine Povacrylex-Alcohol Arm - 6 participants were excluded after treatment administered due to inclusion/exclusion criteria
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| ID | Title | Description |
|---|---|---|
| BG000 | Chlorhexidine-Alcohol | Preoperative Skin Antisepsis Preparation 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation |
| BG001 | Iodine Povacrylex-Alcohol |
| 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 | The Primary Objective Measures the Proportion of Patients With Superficial Site Infection as Defined by the CDC. | The primary objective compares the efficacy of 2% chlorhexidine gluconate / 70% isopropyl alcohol (ChloraPrep) to Iodine Povacrylex [0.7% available Iodine] / 74% Isopropyl Alcohol (DuraPrep) in the prevention of superficial surgical site infection. The primary objective will be measured by the number and percentage of patients with superficial site infection as defined by the CDC. | Posted | Count of Participants | Participants | within 35 days of randomization to treatment assignment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chlorhexidine-Alcohol | Preoperative Skin Antisepsis Preparation 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Najjia Mahmoud, MD, Cheif of Colorectal Surgery | Penn Medicine | (215) 662-2078 | najjia.mahmoud@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| C515331 | DuraPrep |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Iodine Povacrylex/74% Isopropyl Alcohol | Drug | preoperative skin antisepsis preparation |
|
|
| within 35 days of randomization to treatment assignment |
| Number and Percentage of Participants With Deep Wound Infection | within 35 days of randomization to treatment assignment |
| Number and Percentage of Participants With Organ Space Infection | within 35 days of randomization to treatment assignment |
| Length of Hospital Stay | within 35 days of randomization to treatment assignment |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19106 | United States |
Preoperative Skin Antisepsis Preparation
Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Preoperative Skin Antisepsis Preparation Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation |
|
|
| Secondary | Time to Develop Surgical Site Infection | average time from surgery to surgical site infection diagnosis | Posted | Mean | Standard Error | days | within 35 days of randomization to treatment assignment |
|
|
|
| Secondary | Bacterial Pathogens Present in Documented Surgical Site Infection | Posted | Count of Participants | Participants | within 35 days of randomization to treatment assignment |
|
|
|
| Secondary | Number and Percentage of Participants With Deep Wound Infection | Posted | Count of Participants | Participants | within 35 days of randomization to treatment assignment |
|
|
|
| Secondary | Number and Percentage of Participants With Organ Space Infection | Posted | Count of Participants | Participants | within 35 days of randomization to treatment assignment |
|
|
|
| Secondary | Length of Hospital Stay | Posted | Mean | Standard Deviation | days | within 35 days of randomization to treatment assignment |
|
|
|
| 1 |
| 392 |
| 0 |
| 392 |
| 0 |
| 392 |
| EG001 | Iodine Povacrylex-Alcohol | Preoperative Skin Antisepsis Preparation Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation | 1 | 396 | 0 | 396 | 0 | 396 |
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