The Influence of Oral Hygiene on Local Wound and Systemic Infection in Patients With Percutaneous Endoscopic Gastrostomy Placement
Information source: Hillel Yaffe Medical Center
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dysphagia; Peristomal Wound Infection
Intervention: Chlorhexidine gluconate 0.2% (Drug); Plain water (Other)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Hillel Yaffe Medical Center
Summary
Percutaneous endoscopic gastrostomy (PEG) is commonly used for long term enteral feeding of
patients with severe dysphagia. The most common complication is peristomal wound infection.
The possible mechanism the bacterial from the oral cavity disseminate during the PEG
insertion through the stomach to the abdominal wall, in spite the routine use of antibiotic
prophylaxis, have reported low rates of wound infection in patients who were already
receiving antibiotics at the time of PEG Our hypothesis that washing the oral cavity with
antibiotic solution prior the insertion PEG , We planned a prospective, randomised, double
blind, one centre study of antibiotic mouth wash solution (0. 2% Chlorhexidine gluconate)
as. prophylaxis in PEG
Clinical Details
Official title: Predicting Oral Care Before Percutaneous Endoscopic Gastrostomy (PEG). The Influence of Oral Hygiene on Local Wound and Systemic Infection in Patients With PEG Placement
Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Primary outcome: Assess impact mouth wash (containing 0.2% Chlorhexidine gluconate) (Taro Pharmaceutical Industries Haifa Israel) prior PEG insertion.
Secondary outcome: Follow the peristomal wound infection in patients who had prepared by mouth wash to a group a patients without mouth washing.
Eligibility
Minimum age: 45 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- All patients scheduled to undergo PEG
Exclusion Criteria:
- Previous GI surgery
- Coagulopathy
- Sepsis
Locations and Contacts
Additional Information
Starting date: May 2009
Last updated: March 10, 2009
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