Autologous Fibrin Glues for Fistulas Closure

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Adjuvant use of fibrin glue in the fistula tract may promote healing in low-output enterocutaneous fistulas. However, there are only few studies that report autologous glue application in a larger patient group or clinical-controlled studies in this setting. The aim of this study was to investigate the efficacy and safety of autologous platelet-rich fibrin glue (PRFG) in the treatment of low-output digestive fistulas and compare them with conservative management without the use of adjuvant application of FG into the fistulous tract.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jinling Hospital, China
• Treatments: Fibrin Tissue Adhesive; Octreotide

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)