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

H

Hillel Yaffe Medical Center

Status and phase

Unknown
Phase 3

Conditions

Dysphagia
Peristomal Wound Infection

Treatments

Drug: Chlorhexidine gluconate 0.2%
Other: Plain water

Study type

Interventional

Funder types

Other

Identifiers

NCT00859235
HY022009

Details and patient eligibility

About

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

Enrollment

50 estimated patients

Sex

All

Ages

45 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients scheduled to undergo PEG

Exclusion criteria

  • Previous GI surgery
  • Coagulopathy
  • Sepsis

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups, including a placebo group

1
Active Comparator group
Treatment:
Drug: Chlorhexidine gluconate 0.2%
2. Plain water
Placebo Comparator group
Treatment:
Other: Plain water

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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