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Status unknownNCT00859235PEGUpdated Mar 11, 2009

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

A Phase 3 interventional study of Chlorhexidine gluconate 0.2% and Plain water in Dysphagia and Peristomal Wound Infection, sponsored by Hillel Yaffe Medical Center. Status unknown. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-03-11.

Sponsored by Hillel Yaffe Medical Center · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2009), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
All
01

Study 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

02

Conditions studied

  • Dysphagia
  • Peristomal Wound Infection

Keywords

  • Percutaneous endoscopic gastrostomy
  • peristomal wound infection
  • antibiotic mouth wash solution
  • prophylaxis prior Percutaneous endoscopic gastrostomy (PEG)
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 50 is below the median of 120 across 4,200 interventional studies indexed under Infections.

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Lead sponsor

Hillel Yaffe Medical Center is the lead sponsor of 301 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients scheduled to undergo PEG

Exclusion criteria

Exclusion Criteria:

  • Previous GI surgery
  • Coagulopathy
  • Sepsis
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    1

    Drug: Chlorhexidine gluconate 0.2%

  • Placebo comparator
    2. Plain water

    Other: Plain water

Interventions

  • DrugChlorhexidine gluconate 0.2%

    Mouth wash prior to procedure

  • OtherPlain water

    Mouth wash prior to procedure

06

What researchers measure

Primary outcomes

  1. Assess impact mouth wash (containing 0.2% Chlorhexidine gluconate) (Taro Pharmaceutical Industries Haifa Israel) prior PEG insertion.

    Time frame: 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.

    Time frame: One month

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00859235
Lead sponsor
Hillel Yaffe Medical Center
First posted
Mar 11, 2009
Start date
May 2009
Primary completion
Nov 2009 (estimated)
Completion
Dec 2009 (estimated)
Last update
Mar 11, 2009

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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