Ignite Creation Date:
2024-05-06 @ 12:23 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01561066
Status:
COMPLETED
Last Update Posted:
2013-02-26
First Post:
2012-03-16
Brief Title:
Autologous Fibrin Glues for Fistulas Closure
Sponsor:
Jinling Hospital China
Organization:
Jinling Hospital China
Study Overview
Official Title:
Adjuvant Use of Autologous Platelet-rich Fibrin Glue in the Treatment of Fistulas and Anastomotic Leakages of the Digestive Tract
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
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:
None
Brief Summary:
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
Detailed Description:
The sudden appearance of intestinal contents draining from an abdominal incision is an emotionally devastating experience for both patients and surgeons An enterocutaneous fistulas ECF is an abnormal communication between the bowel lumen and skin often associated with fluid and electrolyte abnormalities malnutrition and sepsis It is reported that spontaneous fistula closure rates vary from 15 to 71 after conservative treatment with wound care control of infection and nutritional support Sufficient time should be allotted for the ECF to heal with conservative treatment which also results in long-term discomfort
Adjuvant use of fibrin glue FG in the fistula tract may promote healing in low-output ECF Containing high concentrations of human fibrinogen and thrombin FG have been used extensively in many surgical fields as a biological adhesive system for tissue adhesion or hemostasis Different types of FG are now employed commercially produced and homemade autologous adhesives Currently available FDA-approved commercial products such as Tisseel Artiss Baxter Westlake Village CA USA and Evicel Johnson Johnson Somerville NJ USA are widely used in clinical applications Risks of infection transmission allergic reactions and also the high cost however still make autologous FG attractive Additionally in comparison with other adhesives autologous compounds have several advantages in terms of biocompatibility and biodegradation
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
Adjuvant use of fibrin glue FG in the fistula tract may promote healing in low-output ECF Containing high concentrations of human fibrinogen and thrombin FG have been used extensively in many surgical fields as a biological adhesive system for tissue adhesion or hemostasis Different types of FG are now employed commercially produced and homemade autologous adhesives Currently available FDA-approved commercial products such as Tisseel Artiss Baxter Westlake Village CA USA and Evicel Johnson Johnson Somerville NJ USA are widely used in clinical applications Risks of infection transmission allergic reactions and also the high cost however still make autologous FG attractive Additionally in comparison with other adhesives autologous compounds have several advantages in terms of biocompatibility and biodegradation
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
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