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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
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.
Jinling Hospital
Nanjing, Jiangsu, China
RECRUITINGClosure rates up to 14 days
The fraction of patients with complete closure of fistula during 14 days
Time frame: 14 days
Number of adverse events
Incidence of adverse events and severe adverse events up to 180 days (defined as an event that was fatal or life-threatening, led to additional hospitalization or disability, or required an intervention to prevent one of these outcomes)
Time frame: Participants will be followed for at least 180 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Antibacterial therapy in patients with signs of systemic sepsis or local inflammation with pain
Nutritional replacement and bowel rest via enteral or parenteral nutrition