ACCEL Absorbable Hemostat

Inclusion Criteria:

Pre-Surgery:

1. Subject is greater than or equal to 22 years old

2. Subject is undergoing a cardiovascular surgery, liver surgery or soft tissuesurgical procedure

3. Subject is willing and able to provide appropriate (Institutional Review Board (IRB)approved) informed consent.

4. The subject is willing and able to comply with the requirements of the protocol,including follow-up evaluations and schedule.

5. The subject is willing to be treated with ACCEL® Absorbable Hemostat Powder

6. The subject is willing to be treated with a commercially available absorbablegelatin sponge During Surgery:

7. Subject has not received blood transfusions between screening and application ofinvestigational product or commercially available absorbable gelatin sponge

8. There is an estimated TBS surface area of ≤ 60 cm2

9. Visual observation of oozing (0.01 g/10s ˂ Flow ˂ 0.04 g/10s), mild (0.04 g/10s ≤Flow ˂ 0.32 g/10s), or moderate (0.32 g/10s ≤ Flow ˂ 1.01 g/10s) bleeding asvalidated and when control by conventional surgical techniques, including but notlimited to suture, ligature and cautery, is ineffective and/or impractical

10. There is an absence of intra-operative complications other than bleeding, which, inthe opinion of the Investigator, may interfere with the assessment of efficacy orsafety

11. There has been no intra-operative use of adjunct hemostat(s) on the target bleedingsite identified for application of the study treatment

Exclusion Criteria:

Pre-Surgery:

1. The subject is pregnant (verified in a manner consistent with institution's standardof care)

2. Subject is lactating

3. Subject is currently participating in another investigational device or drug trialor has participated in one in the past 4 weeks (prior to surgery) or is planning toparticipate in another research study involving any investigational product within 4weeks after surgery

4. Subject is a prisoner, a minor or unable to adequately give informed consent due tomental or physical condition

5. Subject has medical, social, or psychosocial issues that the Investigator believescould impact the subject's safety or compliance with study procedures

6. Subject has a known allergy to potatoes

7. Subject has a known allergy to porcine collagen/gelatin

8. Subject has a religious or other objection to porcine products

9. Subject is unwilling to receive blood products

10. Subject has history of heparin-induced thrombocytopenia (only for cardiovascularsubjects where heparin use is required)

11. Subject with a baseline abnormality of INR > 2.5 or an aPTT> 100 seconds duringscreening that is not explained by current drug treatment (e.g. heparin, warfarin,etc.).

12. Subjects with platelets < 100 X 109 PLT/L during screening

13. Subject with Aspartate Aminotransferase (AST) or Alanine aminotransferase (ALT) > 3X upper limit normal range during screening, except for subjects undergoing liverresection surgery or with a diagnosis of liver metastases where there is no upperlimit normal for these analytes due to the nature of their disease

14. Subject is unwilling or unable to return for the required follow-up after surgery During Surgery:

15. Subject has an operative bleeding site which the surgeon is unable or unwilling tocontrol with a hemostatic agent

16. Extracorporeal cardiopulmonary bypass circuits or blood salvage circuits are to beused during or after identification of the TBS.

17. There has been intra-operative use of thrombin on the patient.