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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
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 10, 2009
    Last Updated
    March 10, 2009
    Sponsor
    Hillel Yaffe Medical Center
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    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

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    The Influence of Oral Hygiene on Local Wound and Systemic Infection in Patients With Percutaneous Endoscopic Gastrostomy Placement

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