InfectionNCT04249570
Efficacy of Gastrostomy Tube Coated With Povidone-iodine for Reducing Peristomal Infection Rate After PEG Insertion
A study testing Povidone iodine in people with Infection, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Infection
- What is being tested?
- Povidone iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2014to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of upper abdominal surgery
- Intra-abdominal hemorrhage
- Massive ascites
- Severe coagulopathy
- Malignancy infiltration to the stomach
- Severe left lobe hypertrophy of liver
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Povidone iodine
- Keywords
- percutaneous endoscopic gastrostomy, Povidone-iodine, peristomal infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone iodineOther
Also called Betadine
| Study group | Role | What they receive |
|---|---|---|
| Iodine | Experimental | gastrostomy feeding tube is coated with a layer of Betadine by aseptic gauze before PEG technique Receives: Other: Povidone iodine |
| No iodine | No intervention | gastrostomy feeding tube is not coated with a layer of Betadine by aseptic gauze before PEG technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two weeks
Secondary outcomes (2)
Pneumonia
Diagnosis of aspiration pneumonia after PEG with clinical, biological and radiological :criteria including fever, leucocytes, broncho alveolar secretion, chest radiography and bacteriological identification.
Measured: 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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study startApr 2014
- Primary completionJun 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ming-Chih Hou, MD, Principal investigator, Department of Gastroenterology, Taipei Veterans General Hospital, Taipei, TaiwanYen-Po Wang, Study director, Endoscopy Center for Diagnosis and Treatment, Taipei Veterans General Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249570
- Sponsor's protocol ID
- V103A-012
- Status last verified
- Jan 2020
- First submitted
- 25 Nov 2014
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37189057
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Gastrostomy Tube Coated With Povidone-iodine for Reducing Peristomal Infection Rate After PEG Insertion
- ClinicalTrials.gov ID
- NCT04249570
- Acronym / sponsor ID
- V103A-012
- Conditions
- Infection
- Keywords
- percutaneous endoscopic gastrostomy, Povidone-iodine, peristomal infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Apr 2014
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iodine | Experimental | Other: Povidone iodinegastrostomy feeding tube is coated with a layer of Betadine by aseptic gauze before PEG technique |
| No iodine | No intervention | –gastrostomy feeding tube is not coated with a layer of Betadine by aseptic gauze before PEG technique |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- History of upper abdominal surgery
- Intra-abdominal hemorrhage
- Massive ascites
- Severe coagulopathy
- Malignancy infiltration to the stomach
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Povidone iodineAlso: Betadine | Other | Iodine |
Primary outcome
Peristomal infection rate
Time frame: two weeks
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.
2 secondary outcomes
Pneumonia
Time frame: two weeks
Serum CRP level changes before and after PEG placement
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Derived from this study: PubMed 37189057Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Chih Hou, MD principal investigator
Department of Gastroenterology, Taipei Veterans General Hospital, Taipei, Taiwan
Yen-Po Wang study director
Endoscopy Center for Diagnosis and Treatment, Taipei Veterans General Hospital, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Povidone iodine in people with Infection, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peristomal infection rate (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04249570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.