Ignite Creation Date:
2024-05-06 @ 12:50 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01672593
Status:
UNKNOWN
Last Update Posted:
2014-03-11
First Post:
2012-08-19
Brief Title:
Glue Sealing for Patients With Low-Output ECFs
Sponsor:
Jinling Hospital China
Organization:
Jinling Hospital China
Study Overview
Official Title:
A Randomized Controlled Trial to Evaluate Endoscopy Assisted Fibrin Glue Application in the Treatment of Low-Output ECFs
Status:
UNKNOWN
Status Verified Date:
2014-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Glue-sealing
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None