Clinical Trial: Glue Sealing for Patients With Low-Output ECFs

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized Controlled Trial to Evaluate Endoscopy Assisted Fibrin Glue Application in the Treatment of Low-Output ECFs

Brief Summary: Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output ECFs. The primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG) and a commercially available fibrin sealant Bioseal® in the management of patients with low-output volume ECFs.

Detailed Summary:

  • This is a prospective, randomized, single-centered study clinical, safety and economic outcome of ECFs patients.

  • Subjects are randomized to one of 2 groups:

    • Group 1: Autologous PRFG-treatment (PRFG + SOC)
    • Group 2: Commercial FG-treatment (Bioseal® + SOC)

  • Study will include three phases:

    • Phase 1: Screening, consent and enrollment
    • Phase 2: Patients will receive either PRFG, or Bioseal only for 14 days
    • Phase 3: Follow up: for patients with closed fistula within 14 days, we will follow up them for 6 months. For patients whose fistulas were still open will be treated with other therapeutic option and follow up for 6 months after closure.

Sponsor: Jinling Hospital, China

Current Primary Outcome: Clinical outcome [ Time Frame: 14 days ]

Closure time (defined as the interval between the day of enrollment and day of fistula closure), Closure rate up to 14 days, Closure rate up to 180 days, Fistula recurrence rate


Original Primary Outcome: Same as current

Current Secondary Outcome: Safety outcome [ Time Frame: up to 180 days ]

Incidence of adverse events and severe adverse events up to 180 days (defined as an event that was fatal or life-threatening, led to additional hospitalization or disability, or required an intervention to prevent one of these outcomes)


Original Secondary Outcome: Same as current

Information By: Jinling Hospital, China

Dates:
Date Received: August 19, 2012
Date Started: May 2012
Date Completion: December 2014
Last Updated: March 10, 2014
Last Verified: March 2014