Effect of Topical Sucralfate in Peristomal Wound Reaction prevention in Childre
Phase 3
Recruiting
- Conditions
- Peristomal Wound Reaction due to Endoscopic Percutaneous Gastrostomy.Gastrostomy statusZ93.1
- Registration Number
- IRCT20131119015455N3
- Lead Sponsor
- Esfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
Patient is able to do endoscopy.
There are not any untreated coagulopathy, peritonitis, ascites, bowel obstruction, gastric mucosal abnormalities, previous abdominal surgery at the time of gastrostomy.
Patients are not eligible for anti-inflammatory or antibiotic treatment.
Exclusion Criteria
Severe or advanced pyoderma gangrenosum
Abdominal wall infection
Need to antibiotics or anti-inflammatory medications for any non-reactive periosteal cause
Gastrostomy should be removed for any reason
The drug is not be used in sufficient quantity and duration for any reason
Unwillingness to continue the stydy by parents or the patient
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peristomal Wound Reaction. Timepoint: Evaluation of Peristomal Wound Reaction before intervention and then one week after using the topical sucralfate and then monthly for five months. Method of measurement: Clinical evaluation, Index of Peristomal Wound Reaction grading, Index of Total Daily Peristomal Infection Score.
- Secondary Outcome Measures
Name Time Method Side effects of drug use. Timepoint: After drug use daily for 2 months and then monthly for up to 3 months. Method of measurement: Clinical evaluation.