Clinical Trial: Glue Application in the Treatment of Low-Output Fistulas

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Controlled Trial to Evaluate Fibrin Glue Application in the Treatment of Low-Output Enterocutaneous Fistulas

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

Detailed Summary:

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

  • Subjects are randomized to one of 3 groups:

    • Group 1: Autologous PRFG-treatment [PRFG + Standard of care (SOC)]
    • Group 2: Commercial FG-treatment [FG + Standard of care (SOC)]
    • Group 3: Control (SOC only)

  • Study will include three phases:

    • Phase 1: Screening, consent and enrollment
    • Phase 2: Patients will receive either PRFG, commercial FG, or SOC 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: Closure rates up to 14 days [ Time Frame: 14 days ]

The fraction of patients with complete closure of fistula during 14 days


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of adverse events [ Time Frame: Participants will be followed for at least 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: April 1, 2013
Date Started: March 2014
Date Completion: December 2017
Last Updated: June 9, 2015
Last Verified: June 2015