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Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery

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ClinicalTrials.gov Identifier: NCT01233050
Recruitment Status : Completed
First Posted : November 2, 2010
Results First Posted : September 5, 2017
Last Update Posted : July 18, 2018
Sponsor:
Collaborator:
3M
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Condition Colorectal Surgery
Interventions Drug: 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol
Drug: Iodine Povacrylex/74% Isopropyl Alcohol
Enrollment 802
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chlorhexidine-Alcohol Iodine Povacrylex-Alcohol
Hide Arm/Group Description

Preoperative Skin Antisepsis Preparation

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation

Preoperative Skin Antisepsis Preparation

Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation

Period Title: Overall Study
Started 400 402
Completed 392 [1] 396 [2]
Not Completed 8 6
Reason Not Completed
protocol deviation (inclusion/exclusion)             8             6
[1]
8 participants were excluded after treatment administered due to inclusion/exclusion criteria
[2]
6 participants were excluded after treatment administered due to inclusion/exclusion criteria
Arm/Group Title Chlorhexidine-Alcohol Iodine Povacrylex-Alcohol Total
Hide Arm/Group Description

Preoperative Skin Antisepsis Preparation

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation

Preoperative Skin Antisepsis Preparation

Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation

Total of all reporting groups
Overall Number of Baseline Participants 392 396 788
Hide Baseline Analysis Population Description
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
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 392 participants 396 participants 788 participants
57.33  (16.65) 56.75  (15.81) 57.04  (16.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 392 participants 396 participants 788 participants
Female
202
  51.5%
203
  51.3%
405
  51.4%
Male
190
  48.5%
193
  48.7%
383
  48.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 392 participants 396 participants 788 participants
White Non-Hispanic
307
  78.3%
322
  81.3%
629
  79.8%
African American or Black
64
  16.3%
55
  13.9%
119
  15.1%
Asian
6
   1.5%
6
   1.5%
12
   1.5%
Hispanic or Latino
4
   1.0%
4
   1.0%
8
   1.0%
Other
1
   0.3%
3
   0.8%
4
   0.5%
Unknown
10
   2.6%
6
   1.5%
16
   2.0%
1.Primary Outcome
Title The Primary Objective Measures the Proportion of Patients With Superficial Site Infection as Defined by the CDC.
Time Frame within 35 days of randomization to treatment assignment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chlorhexidine-Alcohol Iodine Povacrylex-Alcohol
Hide Arm/Group Description:

Preoperative Skin Antisepsis Preparation

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation

Preoperative Skin Antisepsis Preparation

Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation

Overall Number of Participants Analyzed 392 396
Measure Type: Count of Participants
Unit of Measure: Participants
40
  10.2%
46
  11.6%
2.Secondary Outcome
Title Time to Develop Surgical Site Infection
Time Frame within 35 days of randomization to treatment assignment
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chlorhexidine-Alcohol Iodine Povacrylex-Alcohol
Hide Arm/Group Description:

Preoperative Skin Antisepsis Preparation

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation

Preoperative Skin Antisepsis Preparation

Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation

Overall Number of Participants Analyzed 392 396
Mean (Standard Error)
Unit of Measure: days
8.0  (0.7) 8.7  (0.6)
3.Secondary Outcome
Title Bacterial Pathogens Present in Documented Surgical Site Infection
Hide Description [Not Specified]
Time Frame within 35 days of randomization to treatment assignment
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chlorhexidine-Alcohol Iodine Povacrylex-Alcohol
Hide Arm/Group Description:

Preoperative Skin Antisepsis Preparation

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation

Preoperative Skin Antisepsis Preparation

Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation

Overall Number of Participants Analyzed 43 26
Measure Type: Count of Participants
Unit of Measure: Participants
43
 100.0%
26
 100.0%
4.Secondary Outcome
Title Number and Percentage of Participants With Deep Wound Infection
Hide Description [Not Specified]
Time Frame within 35 days of randomization to treatment assignment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chlorhexidine-Alcohol Iodine Povacrylex-Alcohol
Hide Arm/Group Description:

Preoperative Skin Antisepsis Preparation

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation

Preoperative Skin Antisepsis Preparation

Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation

Overall Number of Participants Analyzed 392 396
Measure Type: Count of Participants
Unit of Measure: Participants
22
   5.6%
28
   7.1%
5.Secondary Outcome
Title Number and Percentage of Participants With Organ Space Infection
Hide Description [Not Specified]
Time Frame within 35 days of randomization to treatment assignment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chlorhexidine-Alcohol Iodine Povacrylex-Alcohol
Hide Arm/Group Description:

Preoperative Skin Antisepsis Preparation

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation

Preoperative Skin Antisepsis Preparation

Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation

Overall Number of Participants Analyzed 392 396
Measure Type: Count of Participants
Unit of Measure: Participants
20
   5.1%
16
   4.0%
6.Secondary Outcome
Title Length of Hospital Stay
Hide Description [Not Specified]
Time Frame within 35 days of randomization to treatment assignment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chlorhexidine-Alcohol Iodine Povacrylex-Alcohol
Hide Arm/Group Description:

Preoperative Skin Antisepsis Preparation

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation

Preoperative Skin Antisepsis Preparation

Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation

Overall Number of Participants Analyzed 392 396
Mean (Standard Deviation)
Unit of Measure: days
7.0  (3.9) 6.8  (3.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chlorhexidine-Alcohol Iodine Povacrylex-Alcohol
Hide Arm/Group Description

Preoperative Skin Antisepsis Preparation

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation

Preoperative Skin Antisepsis Preparation

Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation

All-Cause Mortality
Chlorhexidine-Alcohol Iodine Povacrylex-Alcohol
Affected / at Risk (%) Affected / at Risk (%)
Total   1/392 (0.26%)   1/396 (0.25%) 
Show Serious Adverse Events Hide Serious Adverse Events
Chlorhexidine-Alcohol Iodine Povacrylex-Alcohol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/392 (0.00%)   0/396 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chlorhexidine-Alcohol Iodine Povacrylex-Alcohol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/392 (0.00%)   0/396 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Najjia Mahmoud, MD, Cheif of Colorectal Surgery
Organization: Penn Medicine
Phone: (215) 662-2078
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01233050     History of Changes
Other Study ID Numbers: EM-05-012087
First Submitted: October 22, 2010
First Posted: November 2, 2010
Results First Submitted: March 20, 2017
Results First Posted: September 5, 2017
Last Update Posted: July 18, 2018