NCT00859235

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2009

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 11, 2009

Status Verified

March 1, 2009

Enrollment Period

6 months

First QC Date

March 10, 2009

Last Update Submit

March 10, 2009

Conditions

DysphagiaPeristomal Wound Infection

Keywords

Percutaneous endoscopic gastrostomyperistomal wound infectionantibiotic mouth wash solutionprophylaxis prior Percutaneous endoscopic gastrostomy (PEG)

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 COMPARATOR
Drug: Chlorhexidine gluconate 0.2%

2. Plain water

PLACEBO COMPARATOR
Other: Plain water

Interventions

Chlorhexidine gluconate 0.2%DRUG

Mouth wash prior to procedure

1
Plain waterOTHER

Mouth wash prior to procedure

2. Plain water

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

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 1, 2009

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

March 11, 2009

Record last verified: 2009-03