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

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.

Study Overview

• Status: Unknown
• Conditions: Infection
• Intervention / Treatment: Other: Povidone iodine

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital, Taiwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Iodine; gastrostomy feeding tube is coated with a layer of Betadine by aseptic gauze before PEG technique	Other: Povidone iodine; Other Names: Betadine
NO_INTERVENTION: No iodine; gastrostomy feeding tube is not coated with a layer of Betadine by aseptic gauze before PEG technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peristomal infection rate	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.	two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumonia	Diagnosis of aspiration pneumonia after PEG with clinical, biological and radiological :criteria including fever, leucocytes, broncho alveolar secretion, chest radiography and bacteriological identification.	two weeks
Serum CRP level changes before and after PEG placement	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.	3 days

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Ming-Chih Hou, MD, Department of Gastroenterology, Taipei Veterans General Hospital, Taipei, Taiwan; Study Director: Yen-Po Wang, Endoscopy Center for Diagnosis and Treatment, Taipei Veterans General Hospital, Taipei, Taiwan

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): July 1, 2020

Study Registration Dates

• First Submitted: November 25, 2014
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (ACTUAL): January 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Povidone-iodine; percutaneous endoscopic gastrostomy; peristomal infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Anti-Infective Agents, Local; Anti-Infective Agents; Plasma Substitutes; Blood Substitutes; Povidone-Iodine; Povidone
• Other Study ID Numbers: V103A-012