Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 1:03 AM
NCT ID:
NCT01672593
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 Description:
* 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.
Study:
NCT01672593
Study Brief:
Protocol Section:
NCT01672593