Trial Outcomes & Findings for Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery (NCT NCT01233050)
NCT ID: NCT01233050
Last Updated: 2018-07-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
802 participants
Primary outcome timeframe
within 35 days of randomization to treatment assignment
Results posted on
2018-07-18
Participant Flow
Participant milestones
| Measure |
Chlorhexidine-Alcohol
Preoperative Skin Antisepsis Preparation
2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation
|
Iodine Povacrylex-Alcohol
Preoperative Skin Antisepsis Preparation
Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation
|
|---|---|---|
|
Overall Study
STARTED
|
400
|
402
|
|
Overall Study
COMPLETED
|
392
|
396
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
Chlorhexidine-Alcohol
Preoperative Skin Antisepsis Preparation
2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation
|
Iodine Povacrylex-Alcohol
Preoperative Skin Antisepsis Preparation
Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation
|
|---|---|---|
|
Overall Study
protocol deviation (inclusion/exclusion)
|
8
|
6
|
Baseline Characteristics
Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery
Baseline characteristics by cohort
| Measure |
Chlorhexidine-Alcohol
n=392 Participants
Preoperative Skin Antisepsis Preparation
2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation
|
Iodine Povacrylex-Alcohol
n=396 Participants
Preoperative Skin Antisepsis Preparation
Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation
|
Total
n=788 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.33 years
STANDARD_DEVIATION 16.65 • n=5 Participants
|
56.75 years
STANDARD_DEVIATION 15.81 • n=7 Participants
|
57.04 years
STANDARD_DEVIATION 16.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
202 Participants
n=5 Participants
|
203 Participants
n=7 Participants
|
405 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
190 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
383 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
307 Participants
n=5 Participants
|
322 Participants
n=7 Participants
|
629 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American or Black
|
64 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 35 days of randomization to treatment assignmentThe 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.
Outcome measures
| Measure |
Chlorhexidine-Alcohol
n=392 Participants
Preoperative Skin Antisepsis Preparation
2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation
|
Iodine Povacrylex-Alcohol
n=396 Participants
Preoperative Skin Antisepsis Preparation
Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation
|
|---|---|---|
|
The Primary Objective Measures the Proportion of Patients With Superficial Site Infection as Defined by the CDC.
|
40 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: within 35 days of randomization to treatment assignmentaverage time from surgery to surgical site infection diagnosis
Outcome measures
| Measure |
Chlorhexidine-Alcohol
n=392 Participants
Preoperative Skin Antisepsis Preparation
2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation
|
Iodine Povacrylex-Alcohol
n=396 Participants
Preoperative Skin Antisepsis Preparation
Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation
|
|---|---|---|
|
Time to Develop Surgical Site Infection
|
8.0 days
Standard Error 0.7
|
8.7 days
Standard Error 0.6
|
SECONDARY outcome
Timeframe: within 35 days of randomization to treatment assignmentOutcome measures
| Measure |
Chlorhexidine-Alcohol
n=43 Participants
Preoperative Skin Antisepsis Preparation
2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation
|
Iodine Povacrylex-Alcohol
n=26 Participants
Preoperative Skin Antisepsis Preparation
Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation
|
|---|---|---|
|
Bacterial Pathogens Present in Documented Surgical Site Infection
|
43 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: within 35 days of randomization to treatment assignmentOutcome measures
| Measure |
Chlorhexidine-Alcohol
n=392 Participants
Preoperative Skin Antisepsis Preparation
2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation
|
Iodine Povacrylex-Alcohol
n=396 Participants
Preoperative Skin Antisepsis Preparation
Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation
|
|---|---|---|
|
Number and Percentage of Participants With Deep Wound Infection
|
22 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: within 35 days of randomization to treatment assignmentOutcome measures
| Measure |
Chlorhexidine-Alcohol
n=392 Participants
Preoperative Skin Antisepsis Preparation
2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation
|
Iodine Povacrylex-Alcohol
n=396 Participants
Preoperative Skin Antisepsis Preparation
Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation
|
|---|---|---|
|
Number and Percentage of Participants With Organ Space Infection
|
20 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: within 35 days of randomization to treatment assignmentOutcome measures
| Measure |
Chlorhexidine-Alcohol
n=392 Participants
Preoperative Skin Antisepsis Preparation
2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation
|
Iodine Povacrylex-Alcohol
n=396 Participants
Preoperative Skin Antisepsis Preparation
Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation
|
|---|---|---|
|
Length of Hospital Stay
|
7.0 days
Standard Deviation 3.9
|
6.8 days
Standard Deviation 3.7
|
Adverse Events
Chlorhexidine-Alcohol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Iodine Povacrylex-Alcohol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Najjia Mahmoud, MD, Cheif of Colorectal Surgery
Penn Medicine
Phone: (215) 662-2078
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place