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

NCT ID: NCT00859235

Last Updated: 2009-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2009-12-31

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

Conditions

Dysphagia; Peristomal Wound Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

Chlorhexidine gluconate 0.2%

Intervention Type: DRUG

Mouth wash prior to procedure

2. Plain water

Group Type: PLACEBO_COMPARATOR

Plain water

Intervention Type: OTHER

Mouth wash prior to procedure

Interventions

Chlorhexidine gluconate 0.2%

Mouth wash prior to procedure

Intervention Type: DRUG

Plain water

Mouth wash prior to procedure

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All patients scheduled to undergo PEG

Exclusion Criteria

• Previous GI surgery
• Coagulopathy
• Sepsis

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hillel Yaffe Med. Ctr.

Other Identifiers

HY022009

Identifier Type: -

Identifier Source: org_study_id