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Effect of Topical Sucralfate in Peristomal Wound Reaction prevention in Children

Evaluation of the Effect of 4% Topical Sucralfate in Peristomal Wound Reaction prevention in Children with Endoscopic Percutaneous Gastrostomy in comparison with control group

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20131119015455N3
Enrollment
44
Registered
2019-12-25
Start date
2019-09-29
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peristomal Wound Reaction due to Endoscopic Percutaneous Gastrostomy. Gastrostomy status

Interventions

Intervention 1: Intervention group: Sucralfate gel 4% (that it will be made in School of Pharmacy and Pharmaceutical Sciences of Isfahan University of Medical Sciences) will be used immediately after

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Months to 18 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Atoosa Mehrannia

Esfahan University of Medical Sciences

atoosamehrannia@gmail.com+98 31 3386 6266

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026