Effectiveness of Two Protocols for Corporal Decolonization in Patients Colonized by Methicillin Resistant Staphylococcus Aureus (MRSA)

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Multicenter Clinical Trial, experimental, randomized and prospective study to determine the effectiveness of two protocols addressing the Corporal Decolonization in patients colonized by Methicillin Resistant Staphylococcus Aureus (MRSA).

PRIMARY END POINT The aim of this trial is to evaluate the effectiveness of the protocol Prontoderm® in the decolonization of MRSA patients, compared with the protocol of the "Consensus Document and GEIH-SEIMC SEMPSPH" (see attached extract from the document, Annex 7).

Prontoderm ® is a Class III Medical Device with CE mark owned by B.BRAUN Medical SA, and currently available in Spain for the same indications proposed in this trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: B. Braun Medical SA
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Chlorhexidine; Chlorhexidine gluconate; Methicillin; Mupirocin

Criteria

Inclusion Criteria:

• MRSA infected or colonized Patients

Exclusion Criteria:

Patients whose condition or treatment interferes with the proper implementation of the proposed protocols, such as:

• Patients admitted to the ICU

• Patients undergoing resuscitation

• Immobilized patients-avoiding their complete hygiene

• Patients carrying nasogastric tube

• Patients with tracheostomy and / or assisted mechanical ventilation

• Patients who are unable, neither they nor their representatives, to give valid informed consent.

• Patients whose discharged is planned before completing protocol