Bacteriuria Clinical Trial
— NosoPinkOfficial title:
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.
Status | Completed |
Enrollment | 270 |
Est. completion date | March 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
France | CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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