Trial Outcomes & Findings for Adjunctive Application of BioFoam Surgical Matrix in Liver Surgery (NCT NCT01458561)

NCT ID: NCT01458561

Last Updated: 2015-05-15

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 1 participants
• Primary outcome timeframe: 3 minutes following a single application of the prescribed hemostatic agent
• Results posted on: 2015-05-15

Participant Flow

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.

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.

Participant milestones

Measure	BioFoam Surgical Matrix Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Gelfoam Plus Control of bleeding using Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Overall Study STARTED	0	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adjunctive Application of BioFoam Surgical Matrix in Liver Surgery

Baseline characteristics by cohort

Measure	BioFoam Surgical Matrix Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Gelfoam Plus n=1 Participants Control of bleeding using Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 participants n=7 Participants	0 participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	1 participants n=7 Participants	1 participants n=5 Participants
Age, Categorical >=65 years	—	0 participants n=7 Participants	0 participants n=5 Participants
Age, Continuous	—	57 years STANDARD_DEVIATION 0 • n=7 Participants	57 years STANDARD_DEVIATION 0 • n=5 Participants
Gender Female	—	0 participants n=7 Participants	0 participants n=5 Participants
Gender Male	—	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 minutes following a single application of the prescribed hemostatic agent

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

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

Outcome measures

Measure	Control Bleeding in BioFoam Subjects/Participants 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 Bleeding in Gelfoam Plus Subjects/Participants n=1 Participants 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
Time to Achieve Intraoperative Hemostasis Following Open Liver Resection Surgery in Subjects Receiving an Application of BioFoam or a Standard Topical Hemostatic Agent	—	1 participants

SECONDARY outcome

Timeframe: 1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent

Population: Study terminated before any subjects were enrolled into the BioFoam arm

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.

Outcome measures

Measure	Control Bleeding in BioFoam Subjects/Participants 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 Bleeding in Gelfoam Plus Subjects/Participants n=1 Participants 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
Time to Hemostasis	—	1 minutes

SECONDARY outcome

Timeframe: 1 minute after application of prescribed hemostatic agent

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

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

Outcome measures

Measure	Control Bleeding in BioFoam Subjects/Participants 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 Bleeding in Gelfoam Plus Subjects/Participants n=1 Participants 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
Achievement of Immediate Hemostasis	—	1 participants

SECONDARY outcome

Timeframe: Time from initial application to confirmed achievement of hemostasis (eval. up to 10 minutes following application of hemostatic agent)

Population: Study terminated before appropriate data collection/analysis

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively

Population: Study terminated before any subjects were enrolled into the BioFoam arm

Outcome measures

Measure	Control Bleeding in BioFoam Subjects/Participants 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 Bleeding in Gelfoam Plus Subjects/Participants n=1 Participants 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
Amount of Postoperative Bilious Drainage	—	NA milliliters (mL) Study terminated before appropriate data collection/analysis

SECONDARY outcome

Timeframe: Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively

Population: Study terminated before any subjects were enrolled into the BioFoam arm

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

Outcome measures

Measure	Control Bleeding in BioFoam Subjects/Participants 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 Bleeding in Gelfoam Plus Subjects/Participants n=1 Participants 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
Amount of Postoperative Fluid Loss	—	NA milliliters (mL) Study terminated before appropriate data collection/analysis

SECONDARY outcome

Timeframe: Time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively

Population: Study terminated before any subjects were enrolled into the BioFoam arm

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

Outcome measures

Measure	Control Bleeding in BioFoam Subjects/Participants 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 Bleeding in Gelfoam Plus Subjects/Participants n=1 Participants 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
Duration of Drainage	—	NA hours Study terminated before appropriate data collection/analysis

SECONDARY outcome

Timeframe: Intraoperatively (throughout procedure, from initial skin cut to final wound closure, average 4-5 hours duration)

Population: Study terminated before any subjects were enrolled into the BioFoam arm

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

Outcome measures

Measure	Control Bleeding in BioFoam Subjects/Participants 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 Bleeding in Gelfoam Plus Subjects/Participants n=1 Participants 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
Amount of Intraoperative Blood Products Administered	—	NA units of blood product(s) Study terminated before appropriate data collection/analysis

SECONDARY outcome

Timeframe: Preoperatively through final 2 year follow-up

Population: Study terminated before any subjects were enrolled into the BioFoam arm

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

Outcome measures

Measure	Control Bleeding in BioFoam Subjects/Participants 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 Bleeding in Gelfoam Plus Subjects/Participants n=1 Participants 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
Subject Laboratory Evaluations	—	NA Number of participants with labs in rang Study terminated before appropriate data collection/analysis

SECONDARY outcome

Timeframe: 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 measures

Measure	Control Bleeding in BioFoam Subjects/Participants 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 Bleeding in Gelfoam Plus Subjects/Participants n=1 Participants 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
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	—	1 participants

SECONDARY outcome

Timeframe: After final wound closure through 2 year follow-up visit (average 2 yr duration)

Population: Study terminated before any subjects were enrolled into the BioFoam arm

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

Outcome measures

Measure	Control Bleeding in BioFoam Subjects/Participants 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 Bleeding in Gelfoam Plus Subjects/Participants n=1 Participants 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
Number of Subjects Requiring Reoperation Due to Bleeding and/or Biliary Leakage (Reoperation Required? y/n)	—	0 number of participants

SECONDARY outcome

Timeframe: Skin cut to skin closure (average 4-5 hour duration)

Population: Study terminated before any subjects were enrolled into the BioFoam arm

Outcome measures

Measure	Control Bleeding in BioFoam Subjects/Participants 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 Bleeding in Gelfoam Plus Subjects/Participants n=1 Participants 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
Total Time of Operative Procedure	—	300 minutes

SECONDARY outcome

Timeframe: At the time of test or control article application (expected average 3-4 hours from skin cut)

Population: Study terminated before any subjects were enrolled into the BioFoam arm

Outcome measures

Measure	Control Bleeding in BioFoam Subjects/Participants 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 Bleeding in Gelfoam Plus Subjects/Participants n=1 Participants 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
Core Body Temperature	—	36.5 degrees Celcius

SECONDARY outcome

Timeframe: Hospital admission (day of surgery) until hospital discharge (average 5-7 days)

Population: Study terminated before any subjects were enrolled into the BioFoam arm

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

Outcome measures

Measure	Control Bleeding in BioFoam Subjects/Participants 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 Bleeding in Gelfoam Plus Subjects/Participants n=1 Participants 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
Total Hospitalization Time	—	NA days Study terminated before appropriate data collection/analysis

SECONDARY outcome

Timeframe: Any hospitalization/surgical intervention following final wound closure through 2 year follow-up visit (average 2 yr duration)

Population: Study terminated before any subjects were enrolled into the BioFoam arm

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

Outcome measures

Measure	Control Bleeding in BioFoam Subjects/Participants 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 Bleeding in Gelfoam Plus Subjects/Participants n=1 Participants 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
Subjects Requiring Additional Hospitalization/Surgical Intervention	—	NA # of participants Study terminated before appropriate data collection/analysis

SECONDARY outcome

Timeframe: 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

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through final follow-up (2 years postoperatively)

Outcome measures

Measure	Control Bleeding in BioFoam Subjects/Participants 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 Bleeding in Gelfoam Plus Subjects/Participants n=1 Participants 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
Number of Procedure Complications and/or Adverse Events	—	31 Number of complications and AEs

Adverse Events

BioFoam Surgical Matrix

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Gelfoam Plus

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	BioFoam Surgical Matrix Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Gelfoam Plus n=1 participants at risk Control of bleeding using Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Recurrence of Hepatocellular Carcinoma	— 0/0	100.0% 1/1 • Number of events 1

Other adverse events

Measure	BioFoam Surgical Matrix Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery	Gelfoam Plus n=1 participants at risk Control of bleeding using Gelfoam Plus as a surgical adjunct Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery
Gastrointestinal disorders Abdominal Hernia	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures Abnormal Monocyte Count	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures Elevated AST	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures Elevated Total Protein	— 0/0	100.0% 1/1 • Number of events 1
Hepatobiliary disorders Hepatic Nodules	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures High ALT	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures High Fibrinogen	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures High GGTP	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures High LDH	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures High WBC	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures Incisional Pain	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures Intermittent Changes in Neutrophil Count (High)	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures Liver Function Tests Elevated ALT & AST	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures Low Bilirubin, Total	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures Low Calcium	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures Low Cholesterol	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures Low Creatinine	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures Low HGB	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures Low Lipase	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures Low Pancreatic Amylase	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures Low Phosphorus	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures Low Sodium	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures Low WBC	— 0/0	100.0% 1/1 • Number of events 1
General disorders Lower Extremity Edema	— 0/0	100.0% 1/1 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pleural Effusion	— 0/0	100.0% 1/1 • Number of events 1
Infections and infestations Sinusitis	— 0/0	100.0% 1/1 • Number of events 1
Cardiac disorders Tachycardia	— 0/0	100.0% 1/1 • Number of events 1
Infections and infestations Upper Respiratory Infection	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures Worsened Baseline Low HCT	— 0/0	100.0% 1/1 • Number of events 1
Surgical and medical procedures Worsened Baseline Low RBC	— 0/0	100.0% 1/1 • Number of events 1

Additional Information

Scott B. Capps, Vice President, Clinical Research

CryoLife, Inc.

Phone: 770-419-3355

Email: capps.scott@cryolife.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER