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.
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Subjects are randomized to one of 2 groups:
- Group 1: Autologous PRFG-treatment (PRFG + SOC)
- Group 2: Commercial FG-treatment (Bioseal® + SOC)
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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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Safety outcome [ Time Frame: up to 180 days ]
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