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

NCT ID: NCT04249570

Last Updated: 2020-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2020-07-31

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.

Conditions

Infection

Keywords

percutaneous endoscopic gastrostomy; Povidone-iodine; peristomal infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Iodine

gastrostomy feeding tube is coated with a layer of Betadine by aseptic gauze before PEG technique

Group Type: EXPERIMENTAL

Povidone iodine

Intervention Type: OTHER

No iodine

gastrostomy feeding tube is not coated with a layer of Betadine by aseptic gauze before PEG technique

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Povidone iodine

Intervention Type: OTHER

Other Intervention Names

Betadine

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming-Chih Hou, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, Taipei Veterans General Hospital, Taipei, Taiwan

Yen-Po Wang

Role: STUDY_DIRECTOR

Endoscopy Center for Diagnosis and Treatment, Taipei Veterans General Hospital, Taipei, Taiwan

Locations

Taipei Veterans General Hospital, Taiwan

Taipei, , Taiwan

Countries

Taiwan

References

Chen YJ, Hou MC, Yang TC, Lee PC, Wang YP, Huang YH, Lee FY. Effectiveness of betadine-coating gastrostomy tube to reduce peristomal infection after percutaneous endoscopic gastrostomy: a randomized controlled trial. BMC Gastroenterol. 2023 May 15;23(1):155. doi: 10.1186/s12876-023-02702-w.

Reference Type: DERIVED

PMID: 37189057 (View on PubMed)

Other Identifiers

V103A-012

Identifier Type: -

Identifier Source: org_study_id