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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
1. 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. 2. 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
Department of Surgery, Jinling Hospital
Nanjing, Jiangsu, China
counting time from enrollment or glue application to fistula closure or healing (d)
The primary measures were defined as the time required for fistula closure and also fistula healing after the last treatment received if in study group, or since enrollment if in control group. Closure was predefined as the absence of drainage through the external openings whether occurring spontaneously or under externally applied pressure. Healing was predefined as complete reepithelialization of external openings.
Time frame: 1-90 days
counting time from enrollment or glue application to enteral intake (d)
For secondary analyses, the time required to resume enteral intake from parenteral nutrition was collected. The hospitalization after enrollment, and also the proportion of patients with recurrence of a healed fistula during 12 months follow-up were evaluated. The incidence of adverse events and severe adverse events (defined as an event that was fatal or life-threatening, led to hospitalization or disability, or required an intervention to prevent one of these outcomes) was determined at each study visit.
Time frame: 1-90 days
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TREATMENT
Masking
NONE
Enrollment
122