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

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

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage
• Intervention / Treatment: Device: SURGICEL Powder; Device: SURGICEL Original

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 234
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hangzhou, China
    • Zhejiang Provincial People's Hospital
  • Nanjing, China
    • Jiangsu Province Hospital
  • Nanjing, China
    • Nanjing Drum Tower Hospital - Nanjing University Medical School
  • Shanghai, China
    • Ruijin Hospital - Shanghai Jiaotong University School of Medicine
  • Shanghai, China
    • Shanghai Xinhua hospital
  • Xuzhou, China
    • The Affiliated Hospital of Xuzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult subjects aged ≥18 years requiring elective/non-emergent open or laparoscopic general, gynecological, or cardiothoracic surgical procedures.
2. Subject or authorized representative has signed the approved Informed Consent.
3. Subject(s) whose platelet count is ≥100,000 per microliter and International Normalized Ratio (INR) is <1.5 prior to 24 hours of surgery.
4. Presence of an appropriate TBS identified intra-operatively by the surgeon.
5. Subject(s) undergoing cardiothoracic surgery with anticoagulation must have anticoagulation reversed prior to TBS identification and treatment.

Exclusion Criteria:

1. Female subjects who are pregnant or nursing.
2. Subject on heparin within 12 hours prior to surgery, or oral Coumadin (warfarin) and/or Factor Xa inhibitors within 3 days prior to surgery.
3. Subject on antiplatelet/P2Y12 inhibitors medication 5 days prior to surgery;
4. Subject is currently participating or plans to participate in any other investigational product or drug trial without prior approval from the Sponsor.
5. Subjects who are known, current alcohol and/or drug abusers.
6. Subjects with any pre-operative findings identified by the surgeon that may preclude conduct of the study procedure.
7. Subjects with any intra-operative findings identified by the surgeon that may preclude the use of study product.
8. Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected; see Appendix 1).
9. 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.
10. Major arterial or venous bleeding or major defects in arteries and veins.
11. TBS where silver nitrate or any other escharotic chemicals have been applied.
12. TBS is in, around, or in proximity to foramina in bone, or areas of bony

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SURGICEL Powder; SURGICEL Powder is an absorbable hemostat that is oxidized regenerated cellulose in a powder form	Device: SURGICEL Powder; 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.
Active Comparator: SURGICEL Original; SURGICEL Original is an bsorbable hemostat that is oxidized regenerated cellulose in a fabric form	Device: SURGICEL Original; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Thromboembolic Events	Number of participants with thrombotic events assessed as unlikely, possibly, probably or related to the study treatment	From enrollment to 30-day follow-up visit
Number of Participants With Post-operative Re-bleeding Events	Number of participants with post-operative re-bleeding events assessed as unlikely, possibly, probably or related to study treatment and requiring medical/surgical intervention	From initiation of final fascial closure to 30-day follow-up visit
Number of Participants With Serious Adverse Events Requiring Surgical Intervention	Number of Participants with Serious Adverse Events requiring surgical intervention and assessed as being unlikely, possibly, probably or related to study treatment	From enrollment to 6 month follow up visit

Collaborators and Investigators

• Sponsor: Ethicon, LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): December 3, 2019
• Study Completion (Actual): May 6, 2020

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: bleeding; broad area oozing bleeding; hemostat; topical hemostatic agents; adjunctive hemostats
• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Hemostatics; Coagulants; Cellulose, Oxidized
• Other Study ID Numbers: BIOS_2017_02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes