Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery

A Randomized Double-Blind Study of 2% Chlorhexidine Gluconate / 70% Isopropyl Alcohol vs Iodine Povacrylex [0.7% Available Iodine] / 74% Isopropyl Alcohol for Perioperative Skin Preparation in Open Elective Colorectal Surgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01233050

Enrollment

802

Registered

2010-11-02

Start date

2010-12-31

Completion date

2015-02-28

Last updated

2018-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Surgery

Keywords

undergoing elective colon and /or rectal surgical procedures involving an abdominal incision

Brief summary

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.

Interventions

DRUG2% Chlorhexidine Gluconate/70% Isopropyl Alcohol

Preoperative skin antisepsis preparation

DRUGIodine Povacrylex/74% Isopropyl Alcohol

preoperative skin antisepsis preparation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. 18 years or older, male or female 2. Undergoing any large bowel procedure with an extraction incision site(including ileostomy closure and Hartman's colostomy reversals). 3. A clean-contaminated preoperative classification. 4. Patient must have decision-making capacity and undergo appropriate informed consent process. 5. Non-pregnant or post menopausal or surgically sterilized females. If of child-bearing age, patients must have a negative (serum or urine) pregnancy prior to surgery.

Exclusion criteria

1. Antibiotics taken within 5 days prior to surgery. 2. Infected wound classification. 3. Preoperative evaluation that may preclude full closure of the skin. 4. Undergoing any bowel procedure that will not result in an extraction incision. 5. Ongoing radiation or chemotherapy treatment. 6. Pregnant. 7. Refusal to accept medically indicated blood products. 8. Current abdominal wall infection or surgical site infection from previous laparotomy / laparoscopy. 9. History of laparotomy within the last 60 days. 10. Known allergy to iodine or to chlorhexidine gluconate. 11. Participating in a preoperative antibiotic trial. 12. Participating in a skin antisepsis trial. 13. Participating in Ulcerative colitis trial conflicting with this trial. 14. Women who are breast feeding (potential for transient hypothyroidism in the nursing newborn).

Design outcomes

Primary

Measure	Time frame	Description
The Primary Objective Measures the Proportion of Patients With Superficial Site Infection as Defined by the CDC.	within 35 days of randomization to treatment assignment	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.

Secondary

Measure	Time frame	Description
Time to Develop Surgical Site Infection	within 35 days of randomization to treatment assignment	average time from surgery to surgical site infection diagnosis
Bacterial Pathogens Present in Documented Surgical Site Infection	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	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
Chlorhexidine-Alcohol Preoperative Skin Antisepsis Preparation 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol: Preoperative skin antisepsis preparation	392
Iodine Povacrylex-Alcohol Preoperative Skin Antisepsis Preparation Iodine Povacrylex/74% Isopropyl Alcohol: preoperative skin antisepsis preparation	396
Total	788

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	protocol deviation (inclusion/exclusion)	8	6

Baseline characteristics

Characteristic	Chlorhexidine-Alcohol	Iodine Povacrylex-Alcohol	Total
Age, Continuous	57.33 years STANDARD_DEVIATION 16.65	56.75 years STANDARD_DEVIATION 15.81	57.04 years STANDARD_DEVIATION 16.22
Race/Ethnicity, Customized African American or Black	64 Participants	55 Participants	119 Participants
Race/Ethnicity, Customized Asian	6 Participants	6 Participants	12 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants	4 Participants	8 Participants
Race/Ethnicity, Customized Other	1 Participants	3 Participants	4 Participants
Race/Ethnicity, Customized Unknown	10 Participants	6 Participants	16 Participants
Race/Ethnicity, Customized White Non-Hispanic	307 Participants	322 Participants	629 Participants
Sex: Female, Male Female	202 Participants	203 Participants	405 Participants
Sex: Female, Male Male	190 Participants	193 Participants	383 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 392	1 / 396
other Total, other adverse events	0 / 392	0 / 396
serious Total, serious adverse events	0 / 392	0 / 396

Outcome results

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.