Prevention of Nosocomial E. Coli Infections After Placement of an Indwelling Catheter During Pelvic Surgery: an Evaluation of Cranberry Gel Capsules (NosoPink)

Prevention of Nosocomial Escherichia Coli Infections After Placement of an Indwelling Catheter During Pelvic Surgery: a Randomized, Prospective, Double Blind Study for the Evaluation of Cranberry (Vaccinium Macrocarpon) Gel Capsules

Indwelling urinary catheters are a primary site for nosocomial infections. The purpose of this study is to evaluate the anti-adhesive properties of Cranberry type A pro anthocyanidine gel capsules in the prevention Escherichia coli infections on indwelling urinary catheters placed in patients following pelvic surgery. The investigators primary working hypothesis is that cranberry treatment decreases E. coli colonization on indwelling urinary catheters, thus preventing nosocomial urinary infections following pelvic surgery.

Study Overview

• Status: Completed
• Conditions: Cross Infection; Bacteriuria
• Intervention / Treatment: Dietary supplement: cranberry type A pro anthocyandines; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient is cared for by the department of the Gynecology at the Nîmes Unversity Hospital
• The patient is programmed for surgery with placement an indwelling catheter for 48 hours with a sterile urinary cytobacteriologic exam at inclusion

Exclusion Criteria:

• the urinary cytobacteriologic exam at inclusion is positive
• the patient is taking antivitamin K
• the patient is taking antibiotics
• history of urolithiasis
• the patient refuses to participate
• the patient is pregnant or nursing
• the patient is not associated with a social security system (no insurance)
• the patient is under guardianship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cranberry; Patients randomized to this arm will recieve one gel capsule containing cranberry PAC (36 mg of type A pro anthocyandines: Urell, Pharmatoka) per day starting at the day of the pelvic surgery (j0) until day 10 postop (j10). The gel capsule in taken orally in the morning with a large glass of water.	Dietary supplement: cranberry type A pro anthocyandines; One gel capsule containing cranberry PAC (36 mg of type A pro anthocyandines: Urell, Pharmatoka) per day starting at the day of the pelvic surgery (j0) until day 10 postop (j10). The gel capsule in taken orally in the morning with a large glass of water
Placebo Comparator: Placebo; The patients randomized to this arm will recieve one placebo gel capsule per day starting on the day of the pelvic surgery (j0) until the 10th day post-op (j10). The gel capsule is taken orally in the morning with a large glass of water. The placebo contains lactose and is conditioned in a manner to be identical in caliber and color with the experimental treatment gel capsules.	Dietary supplement: Placebo; One placebo gel capsule per day starting on the day of the pelvic surgery (j0) until the 10th day post-op (j10). The gel capsule is taken orally in the morning with a large glass of water. The placebo contains lactose and is conditioned in a manner to be identical in caliber and color with the experimental treatment gel capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence/absence of Asymptomatic bacteriuria	Presence/absence of greater than 10^5 unit forming E. coli colonies per ml of urine with absence of functional urinary infection symptoms (mictional burning, pollakiuria, dysuria, urgency, suprapubic heaviness)	15 days post-op

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: April 30, 2010
• First Submitted That Met QC Criteria: April 30, 2010
• First Posted (Estimate): May 3, 2010

Study Record Updates

• Last Update Posted (Estimate): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 25, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Iatrogenic Disease; Urinary Tract Infections; Infections; Communicable Diseases; Bacteriuria; Cross Infection
• Other Study ID Numbers: AOI/2009/VL-01; 2008-AO1604-51 (Other Identifier: Afssaps, RCB number)