Intra-abdominal Infection Clinical Trial
Official title:
Adjuvant Use of Autologous Platelet-rich Fibrin Glue in the Treatment of Fistulas and Anastomotic Leakages of the Digestive Tract
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.
The sudden appearance of intestinal contents draining from an abdominal incision is an
emotionally devastating experience for both patients and surgeons. An enterocutaneous
fistulas (ECF) is an abnormal communication between the bowel lumen and skin, often
associated with fluid and electrolyte abnormalities, malnutrition, and sepsis. It is
reported that spontaneous fistula closure rates vary from 15% to 71% after conservative
treatment with wound care, control of infection, and nutritional support. Sufficient time
should be allotted for the ECF to heal with conservative treatment, which also results in
long-term discomfort.
Adjuvant use of fibrin glue (FG) in the fistula tract may promote healing in low-output ECF.
Containing high concentrations of human fibrinogen and thrombin, FG have been used
extensively in many surgical fields as a biological adhesive system for tissue adhesion or
hemostasis. Different types of FG are now employed: commercially produced and homemade
autologous adhesives. Currently available FDA-approved commercial products such as Tisseel,
Artiss (Baxter, Westlake Village, CA, USA), and Evicel (Johnson & Johnson, Somerville, NJ,
USA) are widely used in clinical applications. Risks of infection transmission, allergic
reactions, and also the high cost, however, still make autologous FG attractive.
Additionally, in comparison with other adhesives, autologous compounds have several
advantages in terms of biocompatibility and biodegradation.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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