Ignite Creation Date:
2025-12-18 @ 3:47 AM
Ignite Modification Date:
2025-12-18 @ 3:47 AM
Study NCT ID:
NCT00762138
Status:
None
Last Update Posted:
2014-02-26 00:00:00
First Post:
2008-09-24 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The AutoloGel™ Post-Market Surveillance (TAPS) Program
Sponsor:
None
Organization:
Study Overview
Official Title:
The AutoloGel™ Post-Market Surveillance (TAPS) Program
Status:
None
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Discontinued due to favorable results
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAPS
Brief Summary:
Device Name.
The device subject to the Post-Market Surveillance (PMS) Program is the AutoloGel™ System which has been cleared for marketing by the Food and Drug Administration (FDA) in the application BK060007.
The AutoloGel™ System includes.
AutoloGel™ Centrifuge II AutoloGel™ System Wound Dressing and Reagent Kits including single-use, disposable components for performing a patient phlebotomy, centrifuging blood to derive PRP and activating and applying the AutoloGel.
The Instructions for Use include a detailed description and procedures for making AutoloGel and a list of the Kit components which is provided at the end of the Instructions.
Indications for Use.
The AutoloGel™ System is intended to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient's own blood. Under the supervision of a healthcare professional, the PRP gel produced by the AutoloGel™ System is suitable for exuding wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and for the management of mechanically or surgically-debrided wounds.
Dosing.
The AutoloGel™ System may be used for chronic or surgically-debrided wounds up to twice a week for eight (8) weeks. The treating health care practitioner may elect to continue the treatment up to twelve (12) weeks. The AutoloGel™ System should be used in conjunction with standard of care procedures for comprehensive wound management.
Removal of necrotic or infected tissue Off-loading Compression therapy for venous stasis ulcers Establishment of adequate blood circulation Maintenance of a moist wound environment Management of wound infection Wound cleansing Nutritional support, including blood glucose control for subjects with diabetic ulcers Bowel and bladder care for subjects with pressure ulcers at risk for contamination Management of underlying disease
Precautions and Warnings.
Caution. Federal Law (U.S.A.) restricts this device to sale by or on the order of a Physician.
Precautions.
Throughout the processing procedure and application of AutoloGel™, use universal precautions as defined by the facility policy and procedure manual.
All parts of the procedure shall be performed in such a manner to minimize splashing, spraying, spattering, and generation of potential droplets.
Warnings.
AutoloGelTM is produced with the use of bovine thrombin. The use of topical bovine thrombin preparations has occasionally been associated with abnormalities of hemostasis ranging from asymptomatic alterations in laboratory determinations, such as prothrombin time (PT) and partial thromboplastin time (PTT), to severe bleeding or thrombosis which have rarely been fatal. These hemostatic effects appear to be related to the formation of antibodies against bovine thrombin and / or factor V which in some cases may cross react with human factor V, potentially resulting in factor V deficiency. Repeated clinical applications of topical bovine thrombin increase the likelihood that antibodies against thrombin and / or factor V may be formed. Consultation with an expert in coagulation disorders is recommended if a patient exhibits abnormal coagulation laboratory values, abnormal bleeding or abnormal thrombosis following the use of topical thrombin. Any interventions should consider the immunologic basis of this condition. Patients with antibodies to bovine thrombin preparations should not be re-exposed to these products.
Allergic reactions may be encountered in persons known to be sensitive to bovine materials. Because of thrombin's action in the clotting mechanism, AutoloGel must not be injected or otherwise allowed to enter large blood vessels. Extensive intravascular clotting and even death may result.
The device subject to the Post-Market Surveillance (PMS) Program is the AutoloGel™ System which has been cleared for marketing by the Food and Drug Administration (FDA) in the application BK060007.
The AutoloGel™ System includes.
AutoloGel™ Centrifuge II AutoloGel™ System Wound Dressing and Reagent Kits including single-use, disposable components for performing a patient phlebotomy, centrifuging blood to derive PRP and activating and applying the AutoloGel.
The Instructions for Use include a detailed description and procedures for making AutoloGel and a list of the Kit components which is provided at the end of the Instructions.
Indications for Use.
The AutoloGel™ System is intended to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient's own blood. Under the supervision of a healthcare professional, the PRP gel produced by the AutoloGel™ System is suitable for exuding wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and for the management of mechanically or surgically-debrided wounds.
Dosing.
The AutoloGel™ System may be used for chronic or surgically-debrided wounds up to twice a week for eight (8) weeks. The treating health care practitioner may elect to continue the treatment up to twelve (12) weeks. The AutoloGel™ System should be used in conjunction with standard of care procedures for comprehensive wound management.
Removal of necrotic or infected tissue Off-loading Compression therapy for venous stasis ulcers Establishment of adequate blood circulation Maintenance of a moist wound environment Management of wound infection Wound cleansing Nutritional support, including blood glucose control for subjects with diabetic ulcers Bowel and bladder care for subjects with pressure ulcers at risk for contamination Management of underlying disease
Precautions and Warnings.
Caution. Federal Law (U.S.A.) restricts this device to sale by or on the order of a Physician.
Precautions.
Throughout the processing procedure and application of AutoloGel™, use universal precautions as defined by the facility policy and procedure manual.
All parts of the procedure shall be performed in such a manner to minimize splashing, spraying, spattering, and generation of potential droplets.
Warnings.
AutoloGelTM is produced with the use of bovine thrombin. The use of topical bovine thrombin preparations has occasionally been associated with abnormalities of hemostasis ranging from asymptomatic alterations in laboratory determinations, such as prothrombin time (PT) and partial thromboplastin time (PTT), to severe bleeding or thrombosis which have rarely been fatal. These hemostatic effects appear to be related to the formation of antibodies against bovine thrombin and / or factor V which in some cases may cross react with human factor V, potentially resulting in factor V deficiency. Repeated clinical applications of topical bovine thrombin increase the likelihood that antibodies against thrombin and / or factor V may be formed. Consultation with an expert in coagulation disorders is recommended if a patient exhibits abnormal coagulation laboratory values, abnormal bleeding or abnormal thrombosis following the use of topical thrombin. Any interventions should consider the immunologic basis of this condition. Patients with antibodies to bovine thrombin preparations should not be re-exposed to these products.
Allergic reactions may be encountered in persons known to be sensitive to bovine materials. Because of thrombin's action in the clotting mechanism, AutoloGel must not be injected or otherwise allowed to enter large blood vessels. Extensive intravascular clotting and even death may result.
Detailed Description:
None
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?: