Autologous Fibrin Glues for Fistulas Closure

Jinling Hospital, China

Status and phase: Completed; Phase 1

Conditions: Intra-abdominal Infection; Enterocutaneous Fistulas

Treatments: Drug: Octreotide; Procedure: Autologous platelet-rich fibrin glue (PRFG)

Study type: Interventional

Funder types: Other

Identifiers

NCT01561066

BRA2011232-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

conservative therapy

Sham Comparator group

Description:

Conservative therapy includes orrection of electrolytic disturbances, suppression of gastric/intestinal secretion with octreotide, nutritional support.

Treatment:

Drug: Octreotide

Application of autologous PRFG

Active Comparator group

Description:

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.

Treatment:

Procedure: Autologous platelet-rich fibrin glue (PRFG)

Drug: Octreotide