drugset / Trial / NCT03920306
A Prospective Evaluation of Non-Operative Treatments for Gastrocutaneous Fistulae in Children
Phase 4
Completed
100 enrolled
University of British Columbia
Montreal Children's Hospital of the MUHC · collabSt. Justine's Hospital · collab
NaSingle-groupOpen-labelPrevention
Summary
Gastrostomy tube placement is a common surgery, and involves placing a tube from the child's skin to the inside of their stomach, allowing an alternative route for nutrition and medication to patients who cannot tolerate oral intake. A common complication of gastrostomy tubes is the development of a persistent connection between the stomach and skin after their removal. This is called a gastrocutaneous fistula (GCF). Non-surgical options have shown some success in eliminating the need for surgery to close these fistulae. Their true efficacy is unknown however; this study evaluates a non-surgical intervention bundle in the prevention and treatment of GCFs.
Timeline
- Start
- 2019-04-01
- Primary completion
- 2024-09-01
- Completion
- 2024-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 2-Octylcyanoacrylate | Small molecule | — | Topical |
| Subject | Fibrinogen Concentrate Human | Protein / enzyme biologic | — | Topical |
| Subject | N-butyl-2-cyanoacrylate | Other / unclassified | — | Topical |
| Subject | Pantoprazole | Other / unclassified | 20 mg | Oral |
| Subject | Pantoprazole | Other / unclassified | 40 mg | Oral |
| Subject | Ranitidine | Unknown | 5 mg/kg | Oral |
| Subject | Ranitidine | Unknown | 10 mg/kg | Oral |
| Subject | Ranitidine | Unknown | 150 mg | Oral |
| Subject | Silver Nitrate | Other / unclassified | — | Topical |