NCT01828892

Glue Application in the Treatment of Low-Output Fistulas

A Randomized Controlled Trial to Evaluate Fibrin Glue Application in the Treatment of Low-Output Enterocutaneous Fistulas

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

* 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.

Conditions

• Low-output External Gastrointestinal Fistula

Interventions

Type	Name	Description
PROCEDURE	Endoscopy exploration and glue application	A forward-viewing fistula-fiberscope (EndoView, Outai Medical Equipment, Shanghai, China), with 15cm length and 5mm width of fiber optical wire, was inserted into the fistula tract to accomplish endoscopic visualization. Briefly, the fistula-fiberscope assisted procedure was carried out percutaneously, allowing the exposure of internal hole and the whole tracts, followed by insertion of this catheter with distal mixing device.
PROCEDURE	Endoscopy exploration	A forward-viewing fistula-fiberscope (EndoView, Outai Medical Equipment, Shanghai, China), with 15cm length and 5mm width of fiber optical wire, was inserted into the fistula tract to accomplish endoscopic visualization.
DRUG	Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)	Antibacterial therapy in patients with signs of systemic sepsis or local inflammation with pain
DIETARY_SUPPLEMENT	Nutrition support	Nutritional replacement and bowel rest via enteral or parenteral nutrition

Timeline

• Start date: 2014-03-01
• Primary completion: 2017-06-01
• Completion: 2017-12-01
• First posted: 2013-04-11
• Last updated: 2015-06-10

Locations

1 site across 1 country: China