The SURGICEL® Powder Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding (China Study)

Study Overview
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Brief Summary
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This is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL Original (control arm) as an adjunct to achieve hemostasis in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective during surgery (open, laparoscopic, or thoracoscopic) in Chinese adult subjects.

Detailed Description
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This is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL Original (control arm) as an adjunct to achieve hemostasis in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective during surgery (open, laparoscopic, or thoracoscopic) in Chinese adult subjects. After application of either SURGICEL Powder or SURGICEL Original, the target bleeding site (TBS) will be assessed for hemostasis (no detectable bleeding) at 3, 5, and 10 minutes from application and prior to initiation of final fascial closure on open surgery or port site closure in laparoscopic or thoracoscopic procedures. All enrolled subjects will be observed post-operatively through discharge and followed up at 30 days (+14 days) and at 6 months (+/-30 days) post-surgery via phone call or office visit.

Official Title
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A Prospective, RCT Evaluating the Safety and Hemostatic Effectiveness of SURGICEL Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding During Surgery in Chinese Adult Subjects

Conditions
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Hemorrhage

Intervention / Treatment
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* Device: SURGICEL Powder
* Device: SURGICEL Original


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subjects aged ≥18 years requiring elective/non-emergent open or laparoscopic general, gynecological, or cardiothoracic surgical procedures. Subject or authorized representative has signed the approved Informed Consent. Subject(s) whose platelet count is ≥100,000 per microliter and International Normalized Ratio (INR) is <1.5 prior to 24 hours of surgery. Presence of an appropriate TBS identified intra-operatively by the surgeon. Subject(s) undergoing cardiothoracic surgery with anticoagulation must have anticoagulation reversed prior to TBS identification and treatment. Exclusion Criteria: Female subjects who are pregnant or nursing. Subject on heparin within 12 hours prior to surgery, or oral Coumadin (warfarin) and/or Factor Xa inhibitors within 3 days prior to surgery. Subject on antiplatelet/P2Y12 inhibitors medication 5 days prior to surgery; Subject is currently participating or plans to participate in any other investigational product or drug trial without prior approval from the Sponsor. Subjects who are known, current alcohol and/or drug abusers. Subjects with any pre-operative findings identified by the surgeon that may preclude conduct of the study procedure. Subjects with any intra-operative findings identified by the surgeon that may preclude the use of study product. Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected; see Appendix 1). TBS is on arteries or veins where application of SURGICEL Powder would present a risk of introducing the study product into an open blood vessel. Major arterial or venous bleeding or major defects in arteries and veins. TBS where silver nitrate or any other escharotic chemicals have been applied. TBS is in, around, or in proximity to foramina in bone, or areas of bony

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SURGICEL Powder<br>SURGICEL Powder is an absorbable hemostat that is oxidized regenerated cellulose in a powder form | Device: SURGICEL Powder<br>* Surgeon to perform surgical procedure according to standard of care. If randomized to SURGICEL Powder, the product will be be applied to the first appropriate TBS with mild or moderate bleeding in parenchyma or soft tissue where conventional methods of control (i.e. suture, ligature, cautery) are ineffective or impractical.<br>|
| Active Comparator: SURGICEL Original<br>SURGICEL Original is an bsorbable hemostat that is oxidized regenerated cellulose in a fabric form | Device: SURGICEL Original<br>* Surgeon to perform surgical procedure according to standard of care. If randomized to SURGICEL Original, the product will be be applied to the first appropriate TBS with mild or moderate bleeding in parenchyma or soft tissue where conventional methods of control (i.e. suture, ligature, cautery) are ineffective or impractical.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostatic Success at 5 Minutes | Percentage of subjects achieving hemostatic success at 5 minutes following study product application with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure | From product application to 5 minutes following product application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostatic Success at 3 Minutes | Percentage of subjects achieving hemostatic success at 3 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure | From product application to 3 minutes following product application | 
| Hemostatic Success at 10 Minutes | Percentage of subjects achieving hemostatic success at 10 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure | From product application to 10 minutes following product application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bleeding, broad area oozing bleeding, hemostat, topical hemostatic agents, adjunctive hemostats