Who is sponsoring NCT01561066?

NCT01561066 is sponsored by Jinling Hospital, China.

What condition does NCT01561066 study?

NCT01561066 studies Enterocutaneous Fistulas, Intra-abdominal Infection.

What drugs are being tested in NCT01561066?

Interventions: Autologous platelet-rich fibrin glue (PRFG), Octreotide.

What is the status of NCT01561066?

NCT01561066 is currently COMPLETED.

Last reviewed 2013-02-23 · How we verify

Adjuvant Use of Autologous Platelet-rich Fibrin Glue in the Treatment of Fistulas and Anastomotic Leakages of the Digestive Tract

NCT01561066 Phase 1 COMPLETED

Adjuvant use of fibrin glue in the fistula tract may promote healing in low-output enterocutaneous fistulas. However, there are only few studies that report autologous glue application in a larger patient group or clinical-controlled studies in this setting. The aim of this study was to investigate the efficacy and safety of autologous platelet-rich fibrin glue (PRFG) in the treatment of low-output digestive fistulas and compare them with conservative management without the use of adjuvant application of FG into the fistulous tract.

Details

Lead sponsor	Jinling Hospital, China
Phase	Phase 1
Status	COMPLETED
Enrolment	122
Start date	2008-01
Completion	2012-01

Conditions

Enterocutaneous Fistulas
Intra-abdominal Infection

Interventions

Autologous platelet-rich fibrin glue (PRFG)
Octreotide

Primary outcomes

counting time from enrollment or glue application to fistula closure or healing (d) — 1-90 days
The primary measures were defined as the time required for fistula closure and also fistula healing after the last treatment received if in study group, or since enrollment if in control group. Closure was predefined as the absence of drainage through the external openings whether occurring spontaneously or under externally applied pressure. Healing was predefined as complete reepithelialization of external openings.

Countries

China