Peripheral Vascular Disease
Conditions
Brief summary
To evaluate a new vascular sealant compared to control for the control of suture line bleeding after vascular reconstructive surgery.
Detailed description
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.
Interventions
DEVICEGelfoam/Thrombin
Gelfoam/Thrombin
DEVICEVascuSeal
VascuSeal
Sponsors
Integra LifeSciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sealing Success | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Immediate Sealing Success at Treated Anastomoses (Anastomoses Level) | 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) | 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 | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 54 |
| 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. | 15 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-Up | Death | 1 | 0 |
| Follow-Up | Late response by subject | 0 | 1 |
| Follow-Up | Lost to Follow-up | 2 | 0 |
| Follow-Up | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | GELFOAM/THROMBIN | VascuSeal | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 24 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 30 Participants | 41 Participants |
| Age, Continuous | 60.91 years STANDARD_DEVIATION 12.958 | 63.45 years STANDARD_DEVIATION 11.773 | 62.51 years STANDARD_DEVIATION 11.904 |
| Region of Enrollment United States | 15 participants | 54 participants | 69 participants |
| Sex: Female, Male Female | 8 Participants | 27 Participants | 35 Participants |
| Sex: Female, Male Male | 7 Participants | 27 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 37 / 54 | 11 / 15 |
| serious Total, serious adverse events | 19 / 54 | 3 / 15 |
Outcome results
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.
Time frame: Within 10 minutes following restoration of blood flow
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VascuSeal | Sealing Success | 90.7 percentage of participants |
| GELFOAM/THROMBIN | Sealing Success | 86.7 percentage of participants |
Comparison: The effectiveness analyses were performed on the ITT population.p-value: 0.072Z-Test
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
Time frame: 60 seconds post restoration of blood flow
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VascuSeal | Proportion of Immediate Sealing Success at Treated Anastomoses (Anastomoses Level) | 51.5 percentage of anastomotic sites |
| GELFOAM/THROMBIN | Proportion of Immediate Sealing Success at Treated Anastomoses (Anastomoses Level) | 10.5 percentage of anastomotic sites |
p-value: 0.006t-test, 2 sided
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.
Time frame: Within 10 minutes post restoration of blood flow
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VascuSeal | Proportion of Overall Sealing Successes at Treated Anastomoses (Anastomoses Level) | 92.6 percentage of anastomitic sites |
| GELFOAM/THROMBIN | Proportion of Overall Sealing Successes at Treated Anastomoses (Anastomoses Level) | 89.5 percentage of anastomitic sites |
p-value: 0.654t-test, 2 sided
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.
Time frame: Within 10 minutes post restoration of blood flow
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| VascuSeal | Time to Hemostasis | 1.0 Minutes |
| GELFOAM/THROMBIN | Time to Hemostasis | 5.0 Minutes |
p-value: 0.089t-test, 2 sided
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.
Time frame: From initial clamp removal at the last anastomotic site until skin closure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| VascuSeal | Time to Wound Closure | 53.5 Minutes |
| GELFOAM/THROMBIN | Time to Wound Closure | 42.5 Minutes |
p-value: 0.404Log Rank