Viewing Study NCT03685604


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Study NCT ID: NCT03685604
Status: COMPLETED
Last Update Posted: 2021-01-26
First Post: 2018-09-10
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: PVP Iodine vs Chlorhexidine in Alcohol for Disinfection of the Surgical Site
Sponsor: University Hospital, Basel, Switzerland
Organization:

Study Overview

Official Title: Polyvinylpyrrolidone (PVP) Iodine vs Chlorhexidine in Alcohol for Disinfection of the Surgical Site: a Cluster-randomized Multicenter Trial
Status: COMPLETED
Status Verified Date: 2021-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PICASSo
Brief Summary: Prospective cluster-randomized multicenter cross-over trial to prove non-inferiority of PI compared to CHX in preoperative skin antisepsis
Detailed Description: Surgical site infections (SSIs) are the most common nosocomial infections in surgical patients causing significant increases in morbidity, mortality, and health care costs. As they are usually caused by components of the normal skin flora, disinfection of the surgical site with an antiseptic skin preparation is standard practice prior to any surgical intervention. The most commonly used disinfectants are either chlorhexidine in alcoholic solution (CHX) or PVP iodine in alcoholic solution (PI) This prospective cluster-randomized multicenter cross-over trial is to prove non-inferiority of PI compared to CHX in preoperative skin antisepsis in abdominal and cardiothoracic surgery in regard of SSIs.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: