Autologous Fibrin Glues for Fistulas Closure
Condition: Enterocutaneous Fistulas; Intra-abdominal Infection
MeSH terms: Intraabdominal Infections; Intestinal Fistula; Fistula
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      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.
    

Intervention name(s): Autologous platelet-rich fibrin glue (PRFG); Octreotide
Intervention type(s): Procedure; Drug
Intervention description(s): Preparation of autologous platelet-rich fibrin glues (PRFG) The platelet-rich plasma (PRP) was separated by centrifugation from 300-400 ml whole blood for 6 min at 1000g, 22°C twice, keeping most of the platelets (50%-60%) in the plasma fraction. For 50g PRP from each patient, with citric acid (2.84mM) lowering and NaHCO3 (75mM) adjusting the PH value, thrombin solution was produced. On the other hand, cryoprecipitate was produced from the rest of the plasma. Frozen at -80°C for at least 6h and then thawed at 4°C, PRP went through centrifugation at 4000rpm/min for 5min.
PRFG application The application of the glues through the external opening of the fistula was controlled by the drainage tube through a double-syringe system with distal mixing device. The distance was based on fistulography to assure total occlusion of the internal hole. After the FG was instilled, any redundant glue was removed from the external openings.; subcutaneous injection, 0.3mg/8h until enteral nutrition resolution
Other intervention name(s): Octreotide Acetate Injection, Novartis, Switzerland
Intervention MeSH terms: Octreotide; Fibrin Tissue Adhesive
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fibrin glue; Platelet; Autologous derivation; Prospective randomized trial; Fistulas