Efficacy of Gastrostomy Tube Coated With Povidone-iodine for Reducing Peristomal Infection Rate After PEG Insertion

Not Applicable

• Conditions: Infection
• Interventions: Other: Povidone iodine

• Registration Number: NCT04249570
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

Percutaneous endoscopic gastrostomy (PEG) was created to replace surgical gastrostomy in patients who are needed long-term tube feeding. PEG has less severe complication rate or mortality rate compared with traditional surgical gastrostomy. However, there are still some mild complications which cannot be completely prevented and peristomal infection is the most common one. Povidone-iodine (PVP-I) exhibits broad range of microbicidal activity via increasing the solubility of iodine. In our study, the gastrostomy feeding tube will be coated with a layer of Betadine before PEG technique.

Investigators expect gastrostomy feeding tube coated with Betadine will reduce the oropharyngeal, esophageal and gastric bacteria colonization rate, followed by reducing peristomal infection rate.

Detailed Description

Percutaneous endoscopic gastrostomy (PEG), or placement of a gastrostomy tube with the aid of an endoscope, was first reported by a pediatrist in 1980. It was created to replace surgical gastrostomy and used widely in patients who are needed long-term tube feeding. There are three kinds of PEG techniques, including pull method, push method and introducer method. Among them, pull method is the most widely accepted technique due to its simplicity of insertion.

PEG has less severe complication rate or mortality rate compared with traditional surgical gastrostomy. However, there are still some mild complications which cannot be completely prevented and peristomal infection is the most common one. The major cause of peristomal infection is that oropharyngeal bacteria colonized gastrostomy feeding tube while undergoing PEG placement with pull method or push method, then bacteria was brought to the stoma via gastrostomy feeding tube and induced peristomal infection.

Povidone-iodine (PVP-I) is a stable chemical complex of polyvinylpyrrolidone (povidone, PVP) and iodine. It exhibits broad range of microbicidal activity via increasing the solubility of iodine. A retrospective study in Japan demonstrated that using Povidone-iodine gargling solution before PEG technique reduced peristomal infection rate. Besides, many studies demonstrated that gingival degerming by Povidone-iodine irrigation prior to extraction or gingivectomy reduced the oral bacterial colonies and postoperative infection rate.

The investigators will use Betadine (10% Povidone iodine) as experimental drug. The gastrostomy feeding tube will be coated with a layer of Betadine by aseptic gauze before PEG technique. Investigators expect that gastrostomy feeding tube coated with Betadine will reduce the oropharyngeal, esophageal and gastric bacteria colonization rate, followed by reducing peristomal infection rate.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-11-25
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-29
• Last Update Submitted: 2020-01-29
• Study First Posted: 2020-01-31
• Last Update Posted: 2020-01-31
• Primary Completion: 2020-06
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients with central nervous system disorder, head and neck cancer, esophageal motility disorder or swallowing dysfunction related to face trauma, who are the candidates for percutaneous endoscopic gastrostomy under doctors' suggestion
• Patients between 20 and 100 years old

Exclusion Criteria

• History of upper abdominal surgery
• Intra-abdominal hemorrhage
• Massive ascites
• Severe coagulopathy
• Malignancy infiltration to the stomach
• Severe left lobe hypertrophy of liver
• High position of transverse colon
• Esophageal stricture
• Thyroid disease
• Allergy to Cephalosporin or Povidine iodine
• Current antibiotics use or use antibiotics in recent 2 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iodine	Povidone iodine	gastrostomy feeding tube is coated with a layer of Betadine by aseptic gauze before PEG technique

Primary Outcome Measures

Name	Time	Method
Peristomal infection rate	two weeks	For each patient, the peristomal area was evaluated daily for 2 weeks after PEG placement. The presence of erythema and of exudate were scored on a scale of 0 to 4; induration was scored on a scale of 0 to 3. Criteria for infection were a maximum combined score of 8 or higher, or the presence of microscopic and microbiologic evidence of suppurating exudate.

Secondary Outcome Measures

Name	Time	Method
Pneumonia	two weeks	Diagnosis of aspiration pneumonia after PEG with clinical, biological and radiological :criteria including fever, leucocytes, broncho alveolar secretion, chest radiography and bacteriological identification.
Serum CRP level changes before and after PEG placement	3 days	Serum CRP level was check before and after PEG placement. The timing was early morning at procedure day and early morning on the next day.

Trial Locations

Locations (1)

Taipei Veterans General Hospital, Taiwan; 🇨🇳 Taipei, Taiwan