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

NCT ID: NCT03783039

Last Updated: 2021-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2020-05-06

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.

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.

Conditions

Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SURGICEL Powder

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

Group Type: EXPERIMENTAL

SURGICEL Powder

Intervention Type: 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 Original

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

Group Type: ACTIVE_COMPARATOR

SURGICEL Original

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhejiang Provincial People's Hospital

Hangzhou, , China

Jiangsu Province Hospital

Nanjing, , China

Nanjing Drum Tower Hospital - Nanjing University Medical School

Nanjing, , China

Ruijin Hospital - Shanghai Jiaotong University School of Medicine

Shanghai, , China

Shanghai Xinhua Hospital

Shanghai, , China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, , China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BIOS_2017_02

Identifier Type: -

Identifier Source: org_study_id