BARRIER: Adjunctive Application of BioFoam Surgical Matrix in Liver Surgery

• Sponsor: CryoLife, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01458561
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 1
• Locations: 2
• Arms: 2
• Duration (Months): 23
• Patients Per Site: 0.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This is a prospective, multicenter, randomized, controlled investigation. Subjects in which bleeding from the exposed parenchymal surface is observed intraoperatively following the ligature of vessels visible with the unaided eye will be randomized to an adjunctive application of BioFoam or a standard topical hemostatic agent (Gelfoam with thrombin, in the form of Gelfoam Plus) to the entire exposed parenchymal surface. Following primary treatment of the exposed parenchymal surface as prescribed by the randomization scheme, treatment sites will be visually evaluated for the continued presence of bleeding. The overall objective of this investigation is to collect clinical data concerning the safety and effectiveness of BioFoam used as an adjunct to conservative measures of achieving hemostasis, such as manual pressure, cautery, and ligation, for intraoperative capillary, arteriolar, and venular bleeding (5 second stack of 5 gauze surface "Bleeding Score" = 1b or 2, score to be validated) on newly resected liver parenchyma in hemodynamically stable (American College of Surgeons' Advanced Trauma Life Support Class I Hemorrhage) and non-coagulopathic patients in the open treatment of exposed liver parenchyma versus a standard topical hemostatic agent, Gelfoam Plus. It is not intended for traumatic liver injury. The investigation will be conducted at a maximum of three investigational sites.

Condition or Disease	Intervention/Treatment	Phase
Intraoperative Bleeding	Device: BioFoam Surgical Matrix; Device: Gelfoam Plus	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: An Investigational Plan Evaluating the Operative Management of Parenchymal Bleeding By Means of an Adjunctive Application of BioFoam Surgical Matrix in Liver Surgery
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BioFoam Surgical Matrix Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct	Device: BioFoam Surgical Matrix; Surgical adjunct to control bleeding in open liver surgery; Other Names: BioFoam
Active Comparator: Gelfoam Plus Control of bleeding using Gelfoam Plus as a surgical adjunct	Device: Gelfoam Plus; Surgical adjunct in control of bleeding in open liver surgery; Other Names: Gelfoam with thrombin

Outcome Measures

Primary Outcome Measures

1. Time to Achieve Intraoperative Hemostasis Following Open Liver Resection Surgery in Subjects Receiving an Application of BioFoam or a Standard Topical Hemostatic Agent [3 minutes following a single application of the prescribed hemostatic agent]

   Number of subjects achieving intraoperative hemostasis (y/n) at 3 minutes following a single application of the prescribed hemostatic agent

Secondary Outcome Measures

1. Time to Hemostasis [1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent]

   Number of subjects achieving hemostasis [by assessing for hemostasis (yes/no)] at pre-determined time points: 1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent. Time to hemostasis is recorded as the first of the predetermined time points to receive a "yes" assessment.

2. Achievement of Immediate Hemostasis [1 minute after application of prescribed hemostatic agent]

   Number of subjects achieving hemostasis at 1 minute after application of prescribed hemostatic agent

3. Intraoperative Blood Loss [Time from initial application to confirmed achievement of hemostasis (eval. up to 10 minutes following application of hemostatic agent)]

   Amount of blood lost between time of initial application of prescribed hemostatic agent and confirmed achievement of hemostasis (achievement of hemostasis eval. out to 10 minutes following application of prescribed hemostatic agent)

4. Amount of Postoperative Bilious Drainage [Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively]

5. Amount of Postoperative Fluid Loss [Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively]

   Amount of fluid lost postoperatively [measured between time of drain insertion (if applicable) to drain removal, average 24-72 hours postoperatively]

6. Duration of Drainage [Time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively]

   Total length of time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively

7. Amount of Intraoperative Blood Products Administered [Intraoperatively (throughout procedure, from initial skin cut to final wound closure, average 4-5 hours duration)]

   Amount of blood products administered intraoperatively (throughout procedure: from initial skin cut to final wound closure)

8. Subject Laboratory Evaluations [Preoperatively through final 2 year follow-up]

   Number of laboratory evaluations outside of range from preoperative assessments through final 2 year follow-up

9. Eval. for Presence of Device by MRI w/ & w/Out Contrast, & Diagnose/Eval. Abdominal Fluid Collection/Biliary Leak, Residual Scarring, Hepatic Regeneration, & Assess for Emergence of Primary/Recurrent Malignancy by MRI w/ or w/Out Contrast as Appropriate [Within 48 hours postoperatively, up to 48 hours prior to hospital discharge (avg. 5-7 days postoperatively), and 30 days, 3 months, 6 months, 9 months, 1 year, and 2 years postoperatively]

10. Number of Subjects Requiring Reoperation Due to Bleeding and/or Biliary Leakage (Reoperation Required? y/n) [After final wound closure through 2 year follow-up visit (average 2 yr duration)]

    Number of subjects requiring reoperation due to bleeding and/or biliary leakage out to 2 years postoperatively (reoperation required? y/n)

11. Total Time of Operative Procedure [Skin cut to skin closure (average 4-5 hour duration)]

12. Core Body Temperature [At the time of test or control article application (expected average 3-4 hours from skin cut)]

13. Total Hospitalization Time [Hospital admission (day of surgery) until hospital discharge (average 5-7 days)]

    Length of time between hospital admission (day of surgery) and hospital discharge (average 5-7 days)

14. Subjects Requiring Additional Hospitalization/Surgical Intervention [Any hospitalization/surgical intervention following final wound closure through 2 year follow-up visit (average 2 yr duration)]

    Number of subjects requiring additional hospitalization/surgical intervention following final wound closure through the 2 year follow-up

15. Evaluation of Anti-Bovine Serum Albumin (Anti-BSA) Antibody Titers [Preoperatively (up to 30 days before surgery), immediately post-application of hemostatic agent (within minutes), within 48 hrs postoperatively, up to 48 hrs before hospital discharge, at 7-10 days, 30 days, 3 mos, 6 mos, 9 mos, 1 yr, and 2 yr postop]

    Evaluation of anti-BSA antibody titers to determine number of subjects/participants with a positive titer at various time points

16. Number of Procedure Complications and/or Adverse Events [Through final follow-up (2 years postoperatively)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Preoperative Inclusion Criteria:

• Subject is undergoing an elective liver resection procedure that requires treatment of the exposed parenchymal surface due to the intraoperative presence of blood following ligature of vessels visible with the unaided eye;

• Subject has adequate hepatic function as indicated by a Model for End-Stage Liver Disease (MELD) score of <10 at ≤30 days and at ≤7 days prior to surgery;

• Subject has adequate hemostatic function identified as an international normalized ratio (INR), platelet count, and activated clotting time within the central laboratory's normal reference range;

• Subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation; and

• Subject is ≥ 18 years of age.

Preoperative Exclusion Criteria:

• Subject with known or suspected sensitivity to products of bovine origin

• Subject with known or suspected sensitivity to glutaraldehyde

• Subject with active infection (either systemic or in the treatment region) or hepatic cysts due to parasitic disease and/or abscesses due to bacterial and/or amebic disease;

• Subject with abnormal calcium metabolism identified as values for ionized calcium and serum calcium corrected for serum albumin that are outside of the central laboratory's normal reference range;

• Subject with abnormal renal status identified as an estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), serum creatinine, sodium, chloride, potassium, and/or bicarbonate values that are outside of the central laboratory's normal reference range;

• Subject with hyperparathyroidism identified as an intact parathyroid hormone level >72 pg/mL, serum calcium >10.6 mg/dL, and phosphate <2.4 mg/dL, and, for secondary or tertiary hyperparathyroidism only, alkaline phosphatase >147 U/L

• Subject with a pancreatic amylase and/or lipase value outside of the central laboratory's normal reference range;

• Subject with blunt and/or penetrating liver trauma;

• Subject diagnosed with any coagulation disorder;

• Subject whose life-expectancy is less than that required for the prescribed follow-up duration;

• Subject who has been treated with an investigational product and has not completed the entire follow-up period for that investigational product;

• Subject with any surgical implant that would interfere with necessary follow-up imaging;

• Subject who is pregnant (as confirmed by a urine pregnancy test), planning on becoming pregnant during the follow-up period, or actively breast-feeding;

• Subject who is undergoing concomitant procedures other than (1) cholecystectomy, (2) umbilical hernia repair, or (3) uncomplicated colon resection (i.e., no significant spillage);

• Subject who is immunocompromised;

• Subject with an American Society of Anesthesiologist (ASA) Score >2

• Subject with a MELD score of ≥10 at ≤30 days or at ≤7 days prior to surgery;

• Subject diagnosed with an autoimmune disease; and

• Subject in whom the surgeon intends to use adhesion prevention products.

• Subject who is returning to the operating room (OR) to address a complication associated with a liver resection, including but not limited to hematoma evacuation and biliary leak.

Intraoperative Inclusion Criterion:

• Subject in whom bleeding (assignment of a "Bleeding Score" of 1 or 2) from the exposed parenchymal surface after ligature of vessels visible with the unaided eye and removal of any clamps used for hemostasis is observed

Intraoperative Exclusion Criterion:

• Subject in whom any major intraoperative bleeding incidences during the resection procedure occurred (i.e., subject with assignment of an American College of Surgeons Advanced Trauma Life Support Hemorrhage Class of II, III, or IV Hemorrhage)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University Medical Center	Palo Alto	California	United States	94304
2	Swedish Medical Center	Seattle	Washington	United States	98122

Sponsors and Collaborators

• CryoLife, Inc.
• United States Department of Defense

Investigators

• Study Director: Scott B Capps, MS, CryoLife, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CryoLife, Inc.
• ClinicalTrials.gov Identifier: NCT01458561
• Other Study ID Numbers: BFM0801-C
• First Posted: Oct 25, 2011
• Last Update Posted: May 15, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by CryoLife, Inc.: Hemostatic agent; Liver surgery; Hemostasis
• Additional relevant MeSH terms: Hemorrhage; Blood Loss, Surgical; Thrombin; Gelatin Sponge, Absorbable

Study Results

Participant Flow

Recruitment Details	Recruitment was limited to potential subjects who were being seen by a liver surgeon because they required a liver resection procedure. The first site was cleared to begin recruitment on October 20, 2010 and recruitment was closed on August 31, 2012 when all investigators were formally notified of the decision to terminate the study.
Pre-assignment Detail	All potential subjects were required to meet preoperative and operative screening criteria in order to be enrolled into the investigation and assigned to a treatment group.

Arm/Group Title	BioFoam Surgical Matrix	Gelfoam Plus
Arm/Group Description	Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Control of bleeding using Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Period Title: Overall Study
STARTED	0	1
COMPLETED	0	1
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	BioFoam Surgical Matrix	Gelfoam Plus	Total
Arm/Group Description	Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Control of bleeding using Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery	Total of all reporting groups
Overall Participants	0	1	1
Age (participants) [Number]
<=18 years	0 NaN	0 0%
Between 18 and 65 years	1 Infinity	1 100%
>=65 years	0 NaN	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57 (0)	57 (0)
Gender (participants) [Number]
Female	0 NaN	0 0%
Male	1 Infinity	1 100%
Region of Enrollment (participants) [Number]
United States	1 Infinity	1 100%

Outcome Measures

1. Primary Outcome

Title	Time to Achieve Intraoperative Hemostasis Following Open Liver Resection Surgery in Subjects Receiving an Application of BioFoam or a Standard Topical Hemostatic Agent
Description	Number of subjects achieving intraoperative hemostasis (y/n) at 3 minutes following a single application of the prescribed hemostatic agent
Time Frame	3 minutes following a single application of the prescribed hemostatic agent

Outcome Measure Data

Analysis Population Description

Study was terminated before any subjects were enrolled into the BioFoam arm

Arm/Group Title	Control Bleeding in BioFoam Subjects/Participants	Control Bleeding in Gelfoam Plus Subjects/Participants
Arm/Group Description	Control of bleeding in subjects/participants who receive BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Control of bleeding in subjects/participants who receive Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Measure Participants	0	1
Number [participants]	1 Infinity

2. Secondary Outcome

Title	Time to Hemostasis
Description	Number of subjects achieving hemostasis [by assessing for hemostasis (yes/no)] at pre-determined time points: 1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent. Time to hemostasis is recorded as the first of the predetermined time points to receive a "yes" assessment.
Time Frame	1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent

Outcome Measure Data

Analysis Population Description

Study terminated before any subjects were enrolled into the BioFoam arm

Arm/Group Title	Subjects/Participants Receiving BioFoam	Subjects/Participants Receiving Gelfoam Plus
Arm/Group Description	Number of subjects achieving hemostasis (y/n) at predetermined time points (1, 3, 5, 7, 10 min) in subjects/participants receiving BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Number of subjects achieving hemostasis (y/n) at predetermined time points (1, 3, 5, 7, 10 min) in subjects/participants receiving Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Measure Participants	0	1
Number [minutes]	1

3. Secondary Outcome

Title	Achievement of Immediate Hemostasis
Description	Number of subjects achieving hemostasis at 1 minute after application of prescribed hemostatic agent
Time Frame	1 minute after application of prescribed hemostatic agent

Outcome Measure Data

Analysis Population Description

Study was terminated before any subjects were enrolled into the BioFoam arm

Arm/Group Title	Achieve Immediate Hemostasis in BioFoam Subjects/Participants	Achievement of Immediate Hemostasis in Gelfoam Plus Subjects
Arm/Group Description	Number of subjects achieving immediate hemostasis (1 minute following application of hemostatic agent) in subjects/participants receiving BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Number of subjects achieving immediate hemostasis (1 minute following application of hemostatic agent) in subjects/participants receiving Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Measure Participants	0	1
Number [participants]	1 Infinity

4. Secondary Outcome

Title	Intraoperative Blood Loss
Description	Amount of blood lost between time of initial application of prescribed hemostatic agent and confirmed achievement of hemostasis (achievement of hemostasis eval. out to 10 minutes following application of prescribed hemostatic agent)
Time Frame	Time from initial application to confirmed achievement of hemostasis (eval. up to 10 minutes following application of hemostatic agent)

Outcome Measure Data

Analysis Population Description

Study terminated before appropriate data collection/analysis

Arm/Group Title	Intraop. Blood Loss in BioFoam Surgical Matrix Subjects	Intraop. Blood Loss in Gelfoam Plus Subjects
Arm/Group Description	Amount of blood lost intraoperatively in subjects receiving BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Amount of blood lost intraoperatively in subjects receiving Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Measure Participants	0	0

5. Secondary Outcome

Title	Amount of Postoperative Bilious Drainage
Time Frame	Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively

Outcome Measure Data

Analysis Population Description

Study terminated before any subjects were enrolled into the BioFoam arm

Arm/Group Title	BioFoam Surgical Matrix	Gelfoam Plus
Arm/Group Description	Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Control of bleeding using Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Measure Participants	0	1
Number [milliliters (mL)]	NA

6. Secondary Outcome

Title	Amount of Postoperative Fluid Loss
Description	Amount of fluid lost postoperatively [measured between time of drain insertion (if applicable) to drain removal, average 24-72 hours postoperatively]
Time Frame	Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively

Outcome Measure Data

Analysis Population Description

Study terminated before any subjects were enrolled into the BioFoam arm

Arm/Group Title	BioFoam Surgical Matrix	Gelfoam Plus
Arm/Group Description	Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Control of bleeding using Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Measure Participants	0	1
Number [milliliters (mL)]	NA

7. Secondary Outcome

Title	Duration of Drainage
Description	Total length of time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively
Time Frame	Time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively

Outcome Measure Data

Analysis Population Description

Study terminated before any subjects were enrolled into the BioFoam arm

Arm/Group Title	Duration of Postoperative Drainage in BioFoam Subjects	Duration of Postoperative Drainage in Gelfoam Plus Subjects
Arm/Group Description	Duration of postoperative drainage in subjects receiving BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Duration of postoperative drainage in subjects receiving Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Measure Participants	0	1
Number [hours]	NA

8. Secondary Outcome

Title	Amount of Intraoperative Blood Products Administered
Description	Amount of blood products administered intraoperatively (throughout procedure: from initial skin cut to final wound closure)
Time Frame	Intraoperatively (throughout procedure, from initial skin cut to final wound closure, average 4-5 hours duration)

Outcome Measure Data

Analysis Population Description

Study terminated before any subjects were enrolled into the BioFoam arm

Arm/Group Title	Amt. of Intraop. Blood Products Rec'd by BioFoam Subjects	Amt. of Intraop. Blood Products Rec'd by Gelfoam Plus Subjects
Arm/Group Description	Amount of blood products administered intraoperatively to subjects receiving BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Amount of blood products administered intraoperatively to subjects receiving Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Measure Participants	0	1
Number [units of blood product(s)]	NA

9. Secondary Outcome

Title	Subject Laboratory Evaluations
Description	Number of laboratory evaluations outside of range from preoperative assessments through final 2 year follow-up
Time Frame	Preoperatively through final 2 year follow-up

Outcome Measure Data

Analysis Population Description

Study terminated before any subjects were enrolled into the BioFoam arm

Arm/Group Title	Laboratory Evaluations for BioFoam Subjects Out of Range	Laboratory Evaluations for Gelfoam Plus Subjects Out of Range
Arm/Group Description	Number of out of range lab evaluations for subjects receiving BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Number of out of range lab evaluations for subjects receiving Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Measure Participants	0	1
Number [Number of participants with labs in rang]	NA NaN

10. Secondary Outcome

Title	Eval. for Presence of Device by MRI w/ & w/Out Contrast, & Diagnose/Eval. Abdominal Fluid Collection/Biliary Leak, Residual Scarring, Hepatic Regeneration, & Assess for Emergence of Primary/Recurrent Malignancy by MRI w/ or w/Out Contrast as Appropriate
Time Frame	Within 48 hours postoperatively, up to 48 hours prior to hospital discharge (avg. 5-7 days postoperatively), and 30 days, 3 months, 6 months, 9 months, 1 year, and 2 years postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Presence of Device Via MRI in BioFoam Surgical Matrix Subjects	Presence of Device Via MRI in Gelfoam Plus Subjects
Arm/Group Description	Evaluation for presence of device via magnetic resonance imaging (MRI) in subjects receiving BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Evaluation for presence of device via magnetic resonance imaging (MRI) in subjects receiving Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Measure Participants	0	1
Number [participants]	1 Infinity

11. Secondary Outcome

Title	Number of Subjects Requiring Reoperation Due to Bleeding and/or Biliary Leakage (Reoperation Required? y/n)
Description	Number of subjects requiring reoperation due to bleeding and/or biliary leakage out to 2 years postoperatively (reoperation required? y/n)
Time Frame	After final wound closure through 2 year follow-up visit (average 2 yr duration)

Outcome Measure Data

Analysis Population Description

Study terminated before any subjects were enrolled into the BioFoam arm

Arm/Group Title	BioFoam Subj. Requiring Reop. Due to Bleeding/Biliary Leakage	Gelfoam Plus Subj. Requiring Reop. Due to Bleeding/Bili. Leak
Arm/Group Description	Number of subjects requiring reoperation due to bleeding and/or biliary leakage in subjects who received BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Number of subjects requiring reoperation due to bleeding and/or biliary leakage in subjects who received Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Measure Participants	0	1
Number [number of participants]	0 NaN

12. Secondary Outcome

Title	Total Time of Operative Procedure
Time Frame	Skin cut to skin closure (average 4-5 hour duration)

Outcome Measure Data

Analysis Population Description

Study terminated before any subjects were enrolled into the BioFoam arm

Arm/Group Title	Total Time of Procedure for BioFoam Surgical Matrix Subjects	Total Time of Procedure for Gelfoam Plus Subjects
Arm/Group Description	Total time of procedure for subjects receiving BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Total time of procedure for subjects receiving Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Measure Participants	0	1
Number [minutes]	300

13. Secondary Outcome

Title	Core Body Temperature
Time Frame	At the time of test or control article application (expected average 3-4 hours from skin cut)

Outcome Measure Data

Analysis Population Description

Study terminated before any subjects were enrolled into the BioFoam arm

Arm/Group Title	Core Body Temp of BioFoam Subjects During Hemostat Application	Core Body Temp of Gelfoam Plus During Hemostat Application
Arm/Group Description	Core body temp during prescribed topical hemostat application for subjects receiving BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Core body temp during prescribed topical hemostat application for subjects receiving Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Measure Participants	0	1
Number [degrees Celcius]	36.5

14. Secondary Outcome

Title	Total Hospitalization Time
Description	Length of time between hospital admission (day of surgery) and hospital discharge (average 5-7 days)
Time Frame	Hospital admission (day of surgery) until hospital discharge (average 5-7 days)

Outcome Measure Data

Analysis Population Description

Study terminated before any subjects were enrolled into the BioFoam arm

Arm/Group Title	Length of Hospital Stay for BioFoam Surgical Matrix Subjects	Length of Hospital Stay for Gelfoam Plus Subjects
Arm/Group Description	Length of hospital stay for subjects receiving BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Length of hospital stay for subjects receiving Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Measure Participants	0	1
Number [days]	NA

15. Secondary Outcome

Title	Subjects Requiring Additional Hospitalization/Surgical Intervention
Description	Number of subjects requiring additional hospitalization/surgical intervention following final wound closure through the 2 year follow-up
Time Frame	Any hospitalization/surgical intervention following final wound closure through 2 year follow-up visit (average 2 yr duration)

Outcome Measure Data

Analysis Population Description

Study terminated before any subjects were enrolled into the BioFoam arm

Arm/Group Title	# of BioFoam Subjects Requiring Hospitalization/Intervention	# of Gelfoam Plus Subj. Requiring Hospitalization/Intervention
Arm/Group Description	Number of subjects receiving BioFoam Surgical Matrix as a surgical adjunct that required hospitalization or intervention following final wound closure through the 2 year follow-up visit BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Number of subjects receiving Gelfoam Plus as a surgical adjunct that required hospitalization or intervention following final wound closure through the 2 year follow-up visit Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Measure Participants	0	1
Number [# of participants]	NA NaN

16. Secondary Outcome

Title	Evaluation of Anti-Bovine Serum Albumin (Anti-BSA) Antibody Titers
Description	Evaluation of anti-BSA antibody titers to determine number of subjects/participants with a positive titer at various time points
Time Frame	Preoperatively (up to 30 days before surgery), immediately post-application of hemostatic agent (within minutes), within 48 hrs postoperatively, up to 48 hrs before hospital discharge, at 7-10 days, 30 days, 3 mos, 6 mos, 9 mos, 1 yr, and 2 yr postop

Outcome Measure Data

Analysis Population Description

Blood samples were to be analyzed in batches to more accurately assess for any changes over time; the study was terminated before the first batch was analyzed, so no data is available for anti-BSA titer testing.

Arm/Group Title	Anti-Bovine Serum Albumin (Anti-BSA) Titers in BioFoam Subj	Anti-Bovine Serum Albumin (Anti-BSA) Titer in Gelfoam Plus Sub
Arm/Group Description	Evaluation of anti-bovine serum albumin (anti-BSA) antibodies in subjects receiving BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Evaluation of anti-bovine serum albumin (anti-BSA) antibodies in subjects receiving Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Measure Participants	0	0

17. Secondary Outcome

Title	Number of Procedure Complications and/or Adverse Events
Time Frame	Through final follow-up (2 years postoperatively)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Complications/Adverse Events in Subjects Receiving BioFoam	Complications/Adverse Events in Subj. Receiving Gelfoam Plus
Arm/Group Description	Number of complications/adverse events recorded for subjects receiving BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Number of complications/adverse events recorded for subjects receiving Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Measure Participants	0	1
Number [Number of complications and AEs]	31

Adverse Events

Arm/Group Title	BioFoam Surgical Matrix		Gelfoam Plus
Arm/Group Description	Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery		Control of bleeding using Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
All Cause Mortality
	BioFoam Surgical Matrix		Gelfoam Plus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	BioFoam Surgical Matrix		Gelfoam Plus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		1/1 (100%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Recurrence of Hepatocellular Carcinoma	0/0 (NaN)	0	1/1 (100%)	1
Other (Not Including Serious) Adverse Events
	BioFoam Surgical Matrix		Gelfoam Plus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		1/1 (100%)
Cardiac disorders
Tachycardia	0/0 (NaN)	0	1/1 (100%)	1
Gastrointestinal disorders
Abdominal Hernia	0/0 (NaN)	0	1/1 (100%)	1
General disorders
Lower Extremity Edema	0/0 (NaN)	0	1/1 (100%)	1
Hepatobiliary disorders
Hepatic Nodules	0/0 (NaN)	0	1/1 (100%)	1
Infections and infestations
Sinusitis	0/0 (NaN)	0	1/1 (100%)	1
Upper Respiratory Infection	0/0 (NaN)	0	1/1 (100%)	1
Respiratory, thoracic and mediastinal disorders
Pleural Effusion	0/0 (NaN)	0	1/1 (100%)	1
Surgical and medical procedures
Abnormal Monocyte Count	0/0 (NaN)	0	1/1 (100%)	1
Elevated AST	0/0 (NaN)	0	1/1 (100%)	1
High ALT	0/0 (NaN)	0	1/1 (100%)	1
High Fibrinogen	0/0 (NaN)	0	1/1 (100%)	1
High GGTP	0/0 (NaN)	0	1/1 (100%)	1
High LDH	0/0 (NaN)	0	1/1 (100%)	1
High WBC	0/0 (NaN)	0	1/1 (100%)	1
Incisional Pain	0/0 (NaN)	0	1/1 (100%)	1
Intermittent Changes in Neutrophil Count (High)	0/0 (NaN)	0	1/1 (100%)	1
Liver Function Tests Elevated ALT & AST	0/0 (NaN)	0	1/1 (100%)	1
Low Calcium	0/0 (NaN)	0	1/1 (100%)	1
Low Cholesterol	0/0 (NaN)	0	1/1 (100%)	1
Low Creatinine	0/0 (NaN)	0	1/1 (100%)	1
Low HGB	0/0 (NaN)	0	1/1 (100%)	1
Low Lipase	0/0 (NaN)	0	1/1 (100%)	1
Low Pancreatic Amylase	0/0 (NaN)	0	1/1 (100%)	1
Low Phosphorus	0/0 (NaN)	0	1/1 (100%)	1
Low Sodium	0/0 (NaN)	0	1/1 (100%)	1
Low WBC	0/0 (NaN)	0	1/1 (100%)	1
Worsened Baseline Low HCT	0/0 (NaN)	0	1/1 (100%)	1
Worsened Baseline Low RBC	0/0 (NaN)	0	1/1 (100%)	1

Limitations/Caveats

Early termination leading to small number of subjects evaluated (n=1).

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Authorship of 1st publication (Primary Paper) determined by Sponsor. If Primary Paper not sub. for publication within 18 months of study completion, Investigator may publish individual publication/presentation - proposal must be provided to Sponsor for review and comment at least 30 days prior to submission date/public disclosure. Sponsor to review within 30 days of receipt and can remove proprietary/confidential info and/or require delay in publication or public disclosure for up to 30 days.