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

NCT03783039 | Completed Results FDA Device

• 1 other identifier: BIOS_2017_02
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Hemorrhage

Keywords

bleeding; broad area oozing bleeding; hemostat; topical hemostatic agents; adjunctive hemostats

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Hemostatic Success at 3 Minutes

  From product application to 3 minutes following product application

• Hemostatic Success at 10 Minutes

  From product application to 10 minutes following product application

Other Outcomes (3)

• Number of Participants With Thromboembolic Events

  From enrollment to 30-day follow-up visit

• Number of Participants With Post-operative Re-bleeding Events

  From initiation of final fascial closure to 30-day follow-up visit

• Number of Participants With Serious Adverse Events Requiring Surgical Intervention

  From enrollment to 6 month follow up visit

Study Arms (2)

SURGICEL Powder

EXPERIMENTAL

SURGICEL Powder is an absorbable hemostat that is oxidized regenerated cellulose in a powder form

Device: SURGICEL Powder

SURGICEL Original

ACTIVE COMPARATOR

SURGICEL Original is an bsorbable hemostat that is oxidized regenerated cellulose in a fabric form

Device: SURGICEL Original

Interventions

SURGICEL Powder DEVICE

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.

SURGICEL Powder

SURGICEL Original DEVICE

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.

SURGICEL Original

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ethicon, LLC: lead

Study Sites (6)

Zhejiang Provincial People's Hospital

Hangzhou, China

Location

Jiangsu Province Hospital

Nanjing, China

Location

Nanjing Drum Tower Hospital - Nanjing University Medical School

Nanjing, China

Location

Ruijin Hospital - Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

Shanghai Xinhua Hospital

Shanghai, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Patricia Schleckser
• Organization: ETHICON, Inc

PSchleck@its.jnj.com

01 908 218 2244

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 20, 2018
• Study Start: January 15, 2019
• Primary Completion: December 3, 2019
• Study Completion: May 6, 2020
• Last Updated: July 8, 2021
• Results First Posted: December 22, 2020

Record last verified: 2021-06

Locations

CN (6)