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

NCT03783039 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2021-07-08

Study results available
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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

Interventions

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.

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.

Sponsors & Collaborators

  • Ethicon, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2019-12-03
Completion
2020-05-06
FDA Device
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03783039 on ClinicalTrials.gov