Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preoperative CHG Cloth on Healthy Subjects

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.
 
ClinicalTrials.gov Identifier: NCT02291601
Recruitment Status : Completed
First Posted : November 14, 2014
Results First Posted : April 30, 2021
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
Medline Industries

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Surgery
Interventions Drug: Chlorhexidine Gluconate
Other: Vehicle
Drug: DynaHex-2
Enrollment 879
Recruitment Details Upon achieving sufficient microbial growth prior to product application on either the abdomen, groin or both abdomen and groin regions, sites of the participant were then randomized to receive one or two products for evaluation for up 4 sites. Differences in the number of participants is based on microbial qualification.
Pre-assignment Details The sites of the participant were tested for microbial activity after product application. In some instances, more than one product could have been applied to a participant but only one product per site (groin and/or abdomen sites). Up to 4 sites could be treated : 1) both groin and abdomen, 2) only the groin or 3) only the abdomen.
Arm/Group Title CHG Cloth Vehicle Comparator CHG
Hide Arm/Group Description CHG 3 min application Vehicle, 3 min application marketed CHG - application done per products instructions for use
Period Title: Abdomen
Number of participants Number of units (sites) Number of participants Number of units (sites) Number of participants Number of units (sites)
Started 638 638 108 108 642 642
Completed [1] 305 [2] 305 54 [3] 54 303 [4] 303
Not Completed 333 333 54 54 339 339
Reason Not Completed
Did not qualify             333                         54                         339            
[1]
Completed is a lower participant number than started due to failed treatment day baselines
[2]
638 participants received CHG cloth
[3]
108 participants received vehicle
[4]
642 participants received comparator CHG
Period Title: Groin
Number of participants Number of units (sites) Number of participants Number of units (sites) Number of participants Number of units (sites)
Started 520 520 93 93 515 515
Completed [1] 337 [2] 337 63 [3] 63 338 [4] 338
Not Completed 183 183 30 30 177 177
Reason Not Completed
Did not qualify             183                         30                         177            
[1]
Completed is a lower participant number than started due to failed treatment day baselines
[2]
520 participants received CHG cloth
[3]
93 participants received vehicle
[4]
515 participants received Comparator CHG
Arm/Group Title CHG, Vehicle, Comparator CHG
Hide Arm/Group Description Single applications of products. 3 min application for CHG and vehicle. Comparator CHG applied according to instructions.
Overall Number of Baseline Participants 879
Hide Baseline Analysis Population Description
The Overall Number of Baseline Participants represents the total number of participants that qualified and were tested.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 879 participants
<=18 years
13
   1.5%
Between 18 and 65 years
829
  94.3%
>=65 years
37
   4.2%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 879 participants
35
(16 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 879 participants
Female
281
  32.0%
Male
598
  68.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 879 participants
879
1.Primary Outcome
Title Percent Responder Rates of Bacterial Reduction on the Abdomen and Groin Sites
Hide Description

Percent of abdomen and groin sites that achieve a 2-Log or 3-Log reduction respectively of bacterial flora from baseline.

Note: The number of participants in each treatment group (abdomen and/or groin) can vary depending on whether participants achieved qualifying microbial levels on the abdomen and groin at baseline.

Time Frame 10 minutes to 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Participants received 1 or 2 products on up to 2 abdomen and 2 groin sites, 2 abdomen only sites or 2 groin sites only.
Arm/Group Title CHG Abdomen CHG Groin Vehicle Abdomen Vehicle Groin Comparator Abdomen Comparator Groin
Hide Arm/Group Description:
single application on abdomen
single application on groin.
single application on abdomen
single application on groin
single application on abdomen
single application of groin
Overall Number of Participants Analyzed 305 337 54 60 303 338
Overall Number of Units Analyzed
Type of Units Analyzed: Sites
305 337 54 60 303 338
Measure Type: Number
Unit of Measure: % of Treated Sites
10 min 80 75 86 65 81 68
6 hours 99 100 97 100 96 100
8 hours 98 100 97 100 96 100
Time Frame [Not Specified]
Adverse Event Reporting Description Qualified and disqualified participants were included in the safety analysis for each treatment group as all of these participants were exposed to one or two different products. In those cases where one participant received 2 products at the same time (on different sites), participants were represented for both products.
 
Arm/Group Title CHG Cloth Vehicle Comparator CHG
Hide Arm/Group Description single application Excipients of CHG product only. 2% CHG solution
All-Cause Mortality
CHG Cloth Vehicle Comparator CHG
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
CHG Cloth Vehicle Comparator CHG
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/755 (0.00%)      0/136 (0.00%)      0/753 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CHG Cloth Vehicle Comparator CHG
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/755 (2.12%)      4/136 (2.94%)      8/753 (1.06%)    
General disorders       
Pain * 1  5/755 (0.66%)  5 0/136 (0.00%)  0 2/753 (0.27%)  2
Injury, poisoning and procedural complications       
Skin Abrasion * 1  0/755 (0.00%)  0 1/136 (0.74%)  1 0/753 (0.00%)  0
Nervous system disorders       
Dizziness * 1  2/755 (0.26%)  2 1/136 (0.74%)  1 1/753 (0.13%)  1
Skin and subcutaneous tissue disorders       
Pruritus * 1  9/755 (1.19%)  9 1/136 (0.74%)  1 3/753 (0.40%)  3
Irritation skin * 1  0/755 (0.00%)  0 1/136 (0.74%)  1 1/753 (0.13%)  1
Rash * 1  0/755 (0.00%)  0 0/136 (0.00%)  0 1/753 (0.13%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Confidential information based on contract
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: C Beausoleil
Organization: Bioscience Labs
Phone: 460-782-5498
EMail: cbeausoleil@biosciencelabs.com
Layout table for additonal information
Responsible Party: Medline Industries
ClinicalTrials.gov Identifier: NCT02291601    
Other Study ID Numbers: R13-052
First Submitted: November 11, 2014
First Posted: November 14, 2014
Results First Submitted: February 3, 2016
Results First Posted: April 30, 2021
Last Update Posted: April 30, 2021