The Influence of Oral Hygiene on Local Wound and Systemic Infection in Patients With Percutaneous Endoscopic Gastrostomy Placement (PEG)
Primary Purpose
Dysphagia, Peristomal Wound Infection
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Chlorhexidine gluconate 0.2%
Plain water
Sponsored by
About this trial
This is an interventional prevention trial for Dysphagia focused on measuring Percutaneous endoscopic gastrostomy, peristomal wound infection, antibiotic mouth wash solution, prophylaxis prior Percutaneous endoscopic gastrostomy (PEG)
Eligibility Criteria
Inclusion Criteria:
- All patients scheduled to undergo PEG
Exclusion Criteria:
- Previous GI surgery
- Coagulopathy
- Sepsis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2. Plain water
Arm Description
Outcomes
Primary Outcome Measures
Assess impact mouth wash (containing 0.2% Chlorhexidine gluconate) (Taro Pharmaceutical Industries Haifa Israel) prior PEG insertion.
Secondary Outcome Measures
Follow the peristomal wound infection in patients who had prepared by mouth wash to a group a patients without mouth washing.
Full Information
NCT ID
NCT00859235
First Posted
March 10, 2009
Last Updated
March 10, 2009
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00859235
Brief Title
The Influence of Oral Hygiene on Local Wound and Systemic Infection in Patients With Percutaneous Endoscopic Gastrostomy Placement
Acronym
PEG
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 Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
November 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Peristomal Wound Infection
Keywords
Percutaneous endoscopic gastrostomy, peristomal wound infection, antibiotic mouth wash solution, prophylaxis prior Percutaneous endoscopic gastrostomy (PEG)
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2. Plain water
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate 0.2%
Intervention Description
Mouth wash prior to procedure
Intervention Type
Other
Intervention Name(s)
Plain water
Intervention Description
Mouth wash prior to procedure
Primary Outcome Measure Information:
Title
Assess impact mouth wash (containing 0.2% Chlorhexidine gluconate) (Taro Pharmaceutical Industries Haifa Israel) prior PEG insertion.
Time Frame
One month
Secondary Outcome Measure Information:
Title
Follow the peristomal wound infection in patients who had prepared by mouth wash to a group a patients without mouth washing.
Time Frame
One month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients scheduled to undergo PEG
Exclusion Criteria:
Previous GI surgery
Coagulopathy
Sepsis
12. IPD Sharing Statement
Learn more about this trial
The Influence of Oral Hygiene on Local Wound and Systemic Infection in Patients With Percutaneous Endoscopic Gastrostomy Placement
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