Autologous Fibrin Glues for Fistulas Closure
Enterocutaneous Fistulas, Intra-abdominal Infection
About this trial
This is an interventional treatment trial for Enterocutaneous Fistulas focused on measuring Fibrin glue, Platelet, Autologous derivation, Prospective randomized trial, Fistulas
Eligibility Criteria
Inclusion Criteria:
- older than 18 years
- presence of one or more fistulas
- fistulas of low-output volume (< 200ml/24h)
Exclusion Criteria:
- failure to meet inclusion criteria
- mental handicap
- extreme thinness
- fistulous tract length < 2 cm
- fistulous tract diameter > 1 cm
- entero-atmospheric fistulas
- Crohn's disease-related fistulas
- any conditions that might impede spontaneous closure of the fistula, such as complex tracts, associated abscesses, residual disease, foreign bodies or distal obstruction
- any conditions that might increase the risk of auto-transfusion, including hypertension, or diabetes; and acquired immune deficiency syndrome (AIDS)
Sites / Locations
- Department of Surgery, Jinling Hospital
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Active Comparator
conservative therapy
Application of autologous PRFG
Conservative therapy includes orrection of electrolytic disturbances, suppression of gastric/intestinal secretion with octreotide, nutritional support.
The application of the glues through the external opening of the fistula was controlled by the drainage tube, which was based on fistulography to assure total occlusion of the internal hole. To allow the adhesion of the fibrin glues patch, all fistulous tracts were debrided to produce a smooth surface. At the time of procedures, the two components were mixed together to yield a gelatinous substance. After the FG was instilled, any redundant glue was removed from the external openings.