Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery

NCT01233050 | Completed Results DMC

• 1 other identifier: EM-05-012087
• Study Type: interventional
• Target: 802
• Locations: 1 country
• Sites: 3

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.

Conditions

Colorectal Surgery

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  within 35 days of randomization to treatment assignment

Secondary Outcomes (5)

• Time to Develop Surgical Site Infection

  within 35 days of randomization to treatment assignment

• 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

Study Arms (2)

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol

ACTIVE COMPARATOR

Preoperative Skin Antisepsis Preparation

Drug: 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol

Iodine Povacrylex/74% Isopropyl Alcohol

ACTIVE COMPARATOR

Preoperative Skin Antisepsis Preparation

Drug: Iodine Povacrylex/74% Isopropyl Alcohol

Interventions

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol DRUG

Preoperative skin antisepsis preparation

Also known as: ChloraPrep

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol

Iodine Povacrylex/74% Isopropyl Alcohol DRUG

preoperative skin antisepsis preparation

Also known as: DuraPrep

Iodine Povacrylex/74% Isopropyl Alcohol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older, male or female
• Undergoing any large bowel procedure with an extraction incision site(including ileostomy closure and Hartman's colostomy reversals).
• A clean-contaminated preoperative classification.
• Patient must have decision-making capacity and undergo appropriate informed consent process.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• 3M: collaborator

Study Sites (3)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19106, United States

Location

Related Publications (2)

• 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.

  PMID: 28277409 DERIVED

• 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.

  PMID: 25322531 DERIVED

MeSH Terms

Interventions

Ethanol; DuraPrep

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: Dr. Najjia Mahmoud, MD, Cheif of Colorectal Surgery
• Organization: Penn Medicine

najjia.mahmoud@uphs.upenn.edu

(215) 662-2078

Study Officials

• Najjia N Mahmoud, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: November 2, 2010
• Study Start: December 1, 2010
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: July 18, 2018
• Results First Posted: September 5, 2017

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)