The Influence of Oral Hygiene on Local Wound and Systemic Infection in Patients With Percutaneous Endoscopic Gastrostomy Placement
PEG
Predicting Oral Care Before Percutaneous Endoscopic Gastrostomy (PEG). The Influence of Oral Hygiene on Local Wound and Systemic Infection in Patients With PEG Placement
Other study identifiers
Sponsor study identifier
interventional
50
0 countries
N/A
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- unknown
- Estimated enrollment
- 50 participants
- Study completion date
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
- Listed locations
- 0 countries · 0 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
March 10, 2009
Actual (reported)First Posted
March 11, 2009
Actual (reported)Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
- Last Updated
- March 11, 2009
- Status Verified
- March 2009
- Last Update Submitted
- March 10, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess impact mouth wash (containing 0.2% Chlorhexidine gluconate) (Taro Pharmaceutical Industries Haifa Israel) prior PEG insertion.
One month
Secondary Outcomes (1)
Follow the peristomal wound infection in patients who had prepared by mouth wash to a group a patients without mouth washing.
One month
Study Arms (2)
1
ACTIVE COMPARATOR2. Plain water
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- All patients scheduled to undergo PEG
You may not qualify if:
- Previous GI surgery
- Coagulopathy
- Sepsis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hillel Yaffe Medical CenterGovernmentlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
March 10, 2009
First Posted
March 11, 2009
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 11, 2009
Record last verified: 2009-03
Source record
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Source: ClinicalTrials.gov.
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- Registry identifier
- NCT00859235
- Data provider
- ClinicalTrials.gov
- Source updated
- 2009-03-11
- Normalization version
- ctgov-legacy-1
Source retrieved: