Efficacy of Gastrostomy Tube Coated With Povidone-iodine for Reducing Peristomal Infection Rate After PEG Insertion
Primary Purpose
Infection
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Povidone iodine
Sponsored by
About this trial
This is an interventional prevention trial for Infection focused on measuring percutaneous endoscopic gastrostomy, Povidone-iodine, peristomal infection
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
Sites / Locations
- Taipei Veterans General Hospital, Taiwan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Iodine
No iodine
Arm Description
gastrostomy feeding tube is coated with a layer of Betadine by aseptic gauze before PEG technique
gastrostomy feeding tube is not coated with a layer of Betadine by aseptic gauze before PEG technique
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pneumonia
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
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.
Full Information
NCT ID
NCT04249570
First Posted
November 25, 2014
Last Updated
January 29, 2020
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT04249570
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
percutaneous endoscopic gastrostomy, Povidone-iodine, peristomal infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Iodine
Arm Type
Experimental
Arm Description
gastrostomy feeding tube is coated with a layer of Betadine by aseptic gauze before PEG technique
Arm Title
No iodine
Arm Type
No Intervention
Arm Description
gastrostomy feeding tube is not coated with a layer of Betadine by aseptic gauze before PEG technique
Intervention Type
Other
Intervention Name(s)
Povidone iodine
Other Intervention Name(s)
Betadine
Primary Outcome Measure Information:
Title
Peristomal infection rate
Description
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.
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
Pneumonia
Description
Diagnosis of aspiration pneumonia after PEG with clinical, biological and radiological :criteria including fever, leucocytes, broncho alveolar secretion, chest radiography and bacteriological identification.
Time Frame
two weeks
Title
Serum CRP level changes before and after PEG placement
Description
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.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Chih Hou, MD
Organizational Affiliation
Department of Gastroenterology, Taipei Veterans General Hospital, Taipei, Taiwan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yen-Po Wang
Organizational Affiliation
Endoscopy Center for Diagnosis and Treatment, Taipei Veterans General Hospital, Taipei, Taiwan
Official's Role
Study Director
Facility Information:
Facility Name
Taipei Veterans General Hospital, Taiwan
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Gastrostomy Tube Coated With Povidone-iodine for Reducing Peristomal Infection Rate After PEG Insertion
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