Clinical trial NCT04249570: Efficacy of Gastrostomy Tube Coated With Povidone-iodine for Reducing Peristomal Infection Rate After PEG Insertion
Official title: Efficacy of Gastrostomy Tube Coated With Povidone-iodine for Reducing Peristomal Infection Rate After PEG Insertion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infection
Keywords: percutaneous endoscopic gastrostomy
Povidone-iodine
peristomal infection
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2020-01-31
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peristomal infection rate
timeFrame: two weeks
Secondary outcomes:
measure: Pneumonia
timeFrame: two weeks
measure: Serum CRP level changes before and after PEG placement
timeFrame: 3 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital, Taiwan
Study officials:
affiliation: Department of Gastroenterology, Taipei Veterans General Hospital, Taipei, Taiwan
name: Ming-Chih Hou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Endoscopy Center for Diagnosis and Treatment, Taipei Veterans General Hospital, Taipei, Taiwan
name: Yen-Po Wang
role: STUDY_DIRECTOR
References: