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Business Decision
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To evaluate a new vascular sealant compared to control for the control of suture line bleeding after vascular reconstructive surgery.
Vascular surgery encompasses a wide range of surgical procedures. In these procedures reduction of blood loss and creation of suture line is of utmost importance to the surgeon. Bleeding at the suture line may require transfusion, as well as prolonged operative and anesthesia time. Suture hole bleeding is common following using synthetic and biological grafts for vascular repair. Several topical hemostatic ans sealing agents have been developed to control suture line bleeding. This new vascular sealant possess high bonding properties, minimal tissue reaction, is biodegradable and absorbed by the body quickly. The primary focus of this study is to compare the safety and effectiveness of the vascular sealant with standard of care methods used today, specifically gelfoam/thrombin and sponge like material.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VascuSeal | Experimental | 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. |
|
| GELFOAM/THROMBIN | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gelfoam/Thrombin | Device | Gelfoam/Thrombin |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Sealing Success | 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. | Within 10 minutes following restoration of blood flow |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Immediate Sealing Success at Treated Anastomoses (Anastomoses Level) | 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 | 60 seconds post restoration of blood flow |
| Proportion of Overall Sealing Successes at Treated Anastomoses (Anastomoses Level) |
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Inclusion Criteria:
Subject was > 18 years of age. Scheduled for elective vascular surgery that entails placement of a PTFE vascular graft including extra-anatomic, infrainguinal bypass, and primary and secondary arteriovenous access procedures. Subject was willing and able to comply with all aspects of the treatment and evaluation schedule. Informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site
Exclusion Criteria:
Subject had a known local or systemic infection. Subjects with known coagulopathies including hemophilia, factor deficiencies, platelet count < 80,000 u/mL, heparin induced thrombocytopenia or uncorrected INR > 1.5. Subject was participating in a clinical trial that requires treatment with another investigational device or drug. Subject was lactating or pregnant, or does not agree to use contraception for the duration of the study. Subject had a known hypersensitivity to any components of bovine thrombin preparations and/or material of bovine origin. The investigator determined that the subject should not be included in the study for reason(s) not already specified
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir I Scerbin | Confluent Surgical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Confluent Surgical, Inc. | Waltham | Massachusetts | 02451 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38695613 | Derived | Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2. |
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Subjects enrolled between 6APR07 & 20MAY08 at: U. Hospitals of Cleveland; Cleveland Clinic; Medical U. of Ohio Toledo; Boston Medical Center; OHSU; Southern Illinois U.; Washington Hospital Center; Penn State Heart & Vascular Inst., Georgetown U.; Brigham & Women's; Methodist Hospital; Vascular & Transplant Specialists; St. Vincent's East
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| ID | Title | Description |
|---|---|---|
| FG000 | VascuSeal | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment |
| |||||||||||||
| Follow-Up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VascuSeal | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sealing Success | 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. | 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. | Posted | Sep 2008 | Number | 95% Confidence Interval | percentage of participants | Within 10 minutes following restoration of blood flow |
|
30 days post randomization
For other adverse events, adverse events were only collected with regard to the affected organ system.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VascuSeal | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coagulopathy | Blood and lymphatic system disorders | MeDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and Lymphatic System Disorder | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Medical Affairs | Integra LifeSciences | 609-275-0500 |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005781 | Gelatin Sponge, Absorbable |
| ID | Term |
|---|---|
| D015503 | Surgical Sponges |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| VascuSeal | Device | VascuSeal |
|
|
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. |
| Within 10 minutes post restoration of blood flow |
| Time to Hemostasis | 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. | Within 10 minutes post restoration of blood flow |
| Time to Wound 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. | From initial clamp removal at the last anastomotic site until skin closure |
| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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.
| OG001 | 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. |
|
|
|
| Secondary | Proportion of Immediate Sealing Success at Treated Anastomoses (Anastomoses Level) | 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 | Posted | Number | percentage of anastomotic sites | 60 seconds post restoration of blood flow | Anastomosis | Anastomosis |
|
|
|
|
| Secondary | Proportion of Overall Sealing Successes at Treated Anastomoses (Anastomoses Level) | 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. | Posted | Number | percentage of anastomitic sites | Within 10 minutes post restoration of blood flow | Anastomosis | Anastomosis |
|
|
|
|
| Secondary | Time to Hemostasis | 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. | Posted | Median | 95% Confidence Interval | Minutes | Within 10 minutes post restoration of blood flow |
|
|
|
|
| Secondary | Time to Wound 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. | Posted | Median | 95% Confidence Interval | Minutes | From initial clamp removal at the last anastomotic site until skin closure |
|
|
|
|
| 19 |
| 54 |
| 37 |
| 54 |
| EG001 | 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. | 3 | 15 | 11 | 15 |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Arteriovenous Graft Site Infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Incision Site Cellulitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Incision Site Infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Septic Shock | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Arteriovenous Graft Thrombosis | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Graft Thrombosis | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Laboratory test Abnormal | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Essential Thrombocythaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Arterial Thrombosis Limb | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Cardiac Disorder | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastrointestinal Disorder | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| General Disorder and Administration Site Conditions | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Infection and Infestation | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injury, Poisoning and Procedural Complications | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Investigations | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Metabolism and Nutrition | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Respiratroy, Thoracic And mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vascular Disorders | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nervous System Disorders | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Surgical and medical Procedures | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
|
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