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:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT01828892
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 Description:
* 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.
Study:
NCT01828892
Study Brief:
Protocol Section:
NCT01828892