Clinical trial NCT01233050: Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Surgery
Keywords: undergoing elective colon and /or rectal surgical procedures involving an abdominal incision
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: 3M
First posted: 2010-11-02
Enrollment: 802
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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).

Primary outcomes:
measure: The Primary Objective Measures the Proportion of Patients With Superficial Site Infection as Defined by the CDC.
timeFrame: within 35 days of randomization to treatment assignment
Secondary outcomes:
measure: Time to Develop Surgical Site Infection
timeFrame: within 35 days of randomization to treatment assignment
measure: Bacterial Pathogens Present in Documented Surgical Site Infection
timeFrame: within 35 days of randomization to treatment assignment
measure: Number and Percentage of Participants With Deep Wound Infection
timeFrame: within 35 days of randomization to treatment assignment
measure: Number and Percentage of Participants With Organ Space Infection
timeFrame: within 35 days of randomization to treatment assignment
measure: Length of Hospital Stay
timeFrame: within 35 days of randomization to treatment assignment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Najjia N Mahmoud, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Broach RB, Paulson EC, Scott C, Mahmoud NN. Randomized Controlled Trial of Two Alcohol-based Preparations for Surgical Site Antisepsis in Colorectal Surgery. Ann Surg. 2017 Dec;266(6):946-951. doi: 10.1097/SLA.0000000000002189.
citation: Poulin P, Chapman K, McGahan L, Austen L, Schuler T. Preoperative skin antiseptics for preventing surgical site infections: what to do? ORNAC J. 2014 Sep;32(3):12-5, 24-9.