Low-output External Gastrointestinal Fistula Clinical Trial
Official title:
A Randomized Controlled Trial to Evaluate Fibrin Glue Application in the Treatment of Low-Output Enterocutaneous Fistulas
Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output enterocutaneous fistulas (ECFs). The primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG), commercial fibrin glue, and control therapy in the management of patients with low-output volume ECFs.
- This is a prospective, randomized, multi-centered study clinical, safety and economic
outcome of ECFs patients.
- Subjects are randomized to one of 3 groups:
- Group 1: Autologous PRFG-treatment [PRFG + Standard of care (SOC)]
- Group 2: Commercial FG-treatment [FG + Standard of care (SOC)]
- Group 3: Control (SOC only)
- Study will include three phases:
- Phase 1: Screening, consent and enrollment
- Phase 2: Patients will receive either PRFG, commercial FG, or SOC only for 14 days
- Phase 3: Follow up: for patients with closed fistula within 14 days, we will
follow up them for 6 months. For patients whose fistulas were still open will be
treated with other therapeutic option and follow up for 6 months after closure.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01672593 -
Glue Sealing for Patients With Low-Output ECFs
|
N/A |