We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01233050
First Posted: November 2, 2010
Last Update Posted: September 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
3M
Information provided by (Responsible Party):
University of Pennsylvania
Results First Submitted: March 20, 2017  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Chlorhexidine-Alcohol   Iodine Povacrylex-Alcohol
STARTED   400   402 
COMPLETED   392 [1]   396 [2] 
NOT COMPLETED   8   6 
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



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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


Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   Chlorhexidine-Alcohol   Iodine Povacrylex-Alcohol   Total 
Overall Participants Analyzed 
[Units: Participants]
 392   396   788 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.33  (16.65)   56.75  (15.81)   57.04  (16.22) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      202  51.5%      203  51.3%      405  51.4% 
Male      190  48.5%      193  48.7%      383  48.6% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White Non-Hispanic   307   322   629 
African American or Black   64   55   119 
Asian   6   6   12 
Hispanic or Latino   4   4   8 
Other   1   3   4 
Unknown   10   6   16 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Time to Develop Surgical Site Infection   [ Time Frame: within 35 days of randomization to treatment assignment ]

3.  Secondary:   Bacterial Pathogens Present in Documented Surgical Site Infection   [ Time Frame: within 35 days of randomization to treatment assignment ]

4.  Secondary:   Number and Percentage of Participants With Deep Wound Infection   [ Time Frame: within 35 days of randomization to treatment assignment ]

5.  Secondary:   Number and Percentage of Participants With Organ Space Infection   [ Time Frame: within 35 days of randomization to treatment assignment ]

6.  Secondary:   Length of Hospital Stay   [ Time Frame: within 35 days of randomization to treatment assignment ]

7.  Secondary:   Analysis of Inappropriately Used Antibiotics   [ Time Frame: within 35 days of randomization to treatment assignment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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
e-mail: najjia.mahmoud@uphs.upenn.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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: September 5, 2017