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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2014-03-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Preventing Urinary Tract Infection Post-Surgery

NCT01346774

Urinary Tract Infection

COMPLETED PHASE2

Cranberry Effect on Urinary Tract Infections

NCT02996981

Urinary Tract Infections

COMPLETED

UTI Prophylaxis With Cranberry Extract After Female Incontinence Surgery

NCT03898310

Urinary Tract Infections Incontinence

COMPLETED NA

Cranberry Tablets Versus Nitrofurantoin Prophylaxis for Urinary Tract Infection Prevention After Urogynecologic Surgery

NCT03522961

Urinary Tract Infections Pelvic Organ Prolapse Urinary Incontinence

ACTIVE_NOT_RECRUITING NA

Urinary Track Infection Prevention After Urogynecological Surgery

NCT03818321

Urinary Tract Infections Urinary Retention Postoperative Pelvic Organ Prolapse

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cross Infection Bacteriuria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

cranberry type A pro anthocyandines

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No