Bacteriuria, Cross Infection
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTcranberry 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
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence/absence of Asymptomatic bacteriuria | 15 days post-op | 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) |
Countries
France
Outcome results
None listed