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

Dysphagia Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00859235
• Other study ID #: HY022009
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 10, 2009
• Last updated: March 10, 2009
• Start date: May 2009
• Est. completion date: December 2009

Study information

• Verified date: March 2009
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• All patients scheduled to undergo PEG

Exclusion Criteria:

• Previous GI surgery

• Coagulopathy

• Sepsis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Dysphagia
• Infection
• Peristomal Wound Infection
• Sepsis
• Wound Infection

Intervention

Drug:
• Chlorhexidine gluconate 0.2%
Mouth wash prior to procedure

Other:
• Plain water
Mouth wash prior to procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess impact mouth wash (containing 0.2% Chlorhexidine gluconate) (Taro Pharmaceutical Industries Haifa Israel) prior PEG insertion.		One month	Yes
Secondary	Follow the peristomal wound infection in patients who had prepared by mouth wash to a group a patients without mouth washing.		One month	Yes