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

• Sponsor: Hillel Yaffe Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00859235
• Collaborator: (none)
• Enrollment: 50
• Arms: 2
• Duration (Months): 7

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Dysphagia; Peristomal Wound Infection	Drug: Chlorhexidine gluconate 0.2%; Other: Plain water	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• 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 Start Date: May 1, 2009
• Anticipated Primary Completion Date: Nov 1, 2009
• Anticipated Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1	Drug: Chlorhexidine gluconate 0.2%; Mouth wash prior to procedure
Placebo Comparator: 2. Plain water	Other: Plain water; Mouth wash prior to procedure

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Follow the peristomal wound infection in patients who had prepared by mouth wash to a group a patients without mouth washing. [One month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All patients scheduled to undergo PEG

Exclusion Criteria:

• Previous GI surgery

• Coagulopathy

• Sepsis

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hillel Yaffe Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00859235
• Other Study ID Numbers: HY022009
• First Posted: Mar 11, 2009
• Last Update Posted: Mar 11, 2009
• Last Verified: Mar 1, 2009

• Keywords provided by , ,: Percutaneous endoscopic gastrostomy; peristomal wound infection; antibiotic mouth wash solution; prophylaxis prior Percutaneous endoscopic gastrostomy (PEG)
• Additional relevant MeSH terms: Infections; Communicable Diseases; Wound Infection; Sepsis; Wounds and Injuries; Chlorhexidine; Chlorhexidine gluconate

Study Results

No Results Posted as of Mar 11, 2009