Study to Evaluate Safety & Effectiveness of Vascular Sealant System
|ClinicalTrials.gov Identifier: NCT00439309|
Recruitment Status : Terminated (Business Decision)
First Posted : February 23, 2007
Results First Posted : April 1, 2014
Last Update Posted : September 7, 2017
|Condition or disease||Intervention/treatment|
|Peripheral Vascular Disease||Device: Gelfoam/Thrombin Device: VascuSeal|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Study to Evaluate Safety & Effectiveness of Vascular Sealant to Control Suture Line Bleeding|
|Study Start Date :||April 2007|
|Primary Completion Date :||May 2008|
|Study Completion Date :||May 2008|
Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
Other Name: Vascular Sealant System
Active Comparator: GELFOAM/THROMBIN
GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
Other Name: absorbable gelatin compressed sponge
- Sealing Success [ Time Frame: Within 10 minutes following restoration of blood flow ]The primary effectiveness endpoint is sealing success defined as complete anastomotic suture line sealing within 10 minutes following restoration of blood flow without use of an adjunctive hemostatic technique different from the assigned treatment. The primary effectiveness endpoint was evaluated on a per subject basis. For subjects with two treated sites, the subject is considered a success only if there is complete anastomotic suture line sealing within 10 minutes at both sites.
- Proportion of Immediate Sealing Success at Treated Anastomoses (Anastomoses Level) [ Time Frame: 60 seconds post restoration of blood flow ]A site with no suture line bleeding after blood flow is restored and monitored for a minimum period of 60 seconds to confirm cessation of blood flow
- Proportion of Overall Sealing Successes at Treated Anastomoses (Anastomoses Level) [ Time Frame: Within 10 minutes post restoration of blood flow ]A site with no suture line bleeding after blood flow is restored and monitored for a minimum period of 60 seconds to confirm cessation of blood flow.
- Time to Hemostasis [ Time Frame: Within 10 minutes post restoration of blood flow ]Time to hemostasis determined from time circulation restored after treatment application until bleeding stopped (assessed at intervals of immediate, 1, 3, 5, 7.5 and 10 min). For subject with two sites, time to hemostasis of both sites used for analysis. Subjects for whom bleeding had not stopped within 10 min considered censored observations.
- Time to Wound Closure [ Time Frame: From initial clamp removal at the last anastomotic site until skin closure ]Time to wound closure was defined as the elapsed time between initial clamp removal at the last anastomotic site until skin closure. This endpoint was analyzed using the log-rank test to compare the two treatment groups. The Kaplan-Meier method was used to obtain estimated median times to wound closure and the corresponding 95% confidence intervals for each treatment group.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439309
|United States, Massachusetts|
|Confluent Surgical, Inc.|
|Waltham, Massachusetts, United States, 02451|
|Study Director:||Vladimir I Scerbin||Confluent Surgical|