Autologous Fibrin Glues for Fistulas Closure

NCT01561066 | Completed Phase 1 DMC

• 1 other identifier: BRA2011232-1
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Enterocutaneous Fistulas; Intra-abdominal Infection

Keywords

Fibrin glue; Platelet; Autologous derivation; Prospective randomized trial; Fistulas

Outcome Measures

Primary Outcomes (1)

• 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.

  1-90 days

Secondary Outcomes (1)

• counting time from enrollment or glue application to enteral intake (d)

  1-90 days

Study Arms (2)

conservative therapy

SHAM COMPARATOR

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

Drug: Octreotide

Application of autologous PRFG

ACTIVE COMPARATOR

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.

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

Interventions

Autologous platelet-rich fibrin glue (PRFG) PROCEDURE

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.

Application of autologous PRFG

Octreotide DRUG

subcutaneous injection, 0.3mg/8h until enteral nutrition resolution

Also known as: Octreotide Acetate Injection, Novartis, Switzerland

Application of autologous PRFG; conservative therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older than 18 years
• presence of one or more fistulas
• fistulas of low-output volume (\< 200ml/24h)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Department of Surgery, Jinling Hospital

Nanjing, Jiangsu, 210002, China

Location

Related Publications (1)

• Wu X, Ren J, Gu G, Wang G, Han G, Zhou B, Ren H, Yao M, Driver VR, Li J. Autologous platelet rich fibrin glue for sealing of low-output enterocutaneous fistulas: an observational cohort study. Surgery. 2014 Mar;155(3):434-41. doi: 10.1016/j.surg.2013.09.001. Epub 2013 Oct 29.

  PMID: 24183344 DERIVED

MeSH Terms

Conditions

Intestinal Fistula; Intraabdominal Infections; Fistula

Interventions

Octreotide; lactitol

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infections

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor, Principal investigator

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 22, 2012
• Study Start: January 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 26, 2013

Record last verified: 2013-02

Locations

CN (1)