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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04249570
• Other study ID #: V103A-012
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 2014
• Est. completion date: July 2020

Study information

• Verified date: January 2020
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: July 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection

Intervention

Other:
• Povidone iodine

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital, Taiwan	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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