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

Centre Hospitalier Universitaire de Nīmes

Status and phase: Completed; Phase 2

Conditions: Cross Infection; Bacteriuria

Treatments: Dietary Supplement: cranberry type A pro anthocyandines; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01114347

AOI/2009/VL-01

2009-A01317-50 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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270 participants in 2 patient groups, including a placebo group

Cranberry

Experimental group

Description:

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.

Treatment:

Dietary Supplement: cranberry type A pro anthocyandines

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo