Traumacel PULVIS and Traumacel ENDO Applicator in the Post-market Surveillance Phase

Multicentric, Prospective Clinical Study of Traumacel PULVIS Haemostatic Powder Application With or Without the Use of Traumacel ENDO Applicator in the Post-market Surveillance Phase

Traumacel PULVIS is a sterile absorbable haemostatic plant polysaccharide powder made of the oxidized cellulose. Traumacel PULVIS is designed to stop capillary bleeding as well as to prevent bleeding in the early post-operative stage, for example to stop capillary bleeding from resection areas of parenchymatous organs, muscles, to stop bleeding after endoscopy, mainly rectoscopic, procedures. The broadness of application allows for use in procedures performed in the standard way as well as endoscopically.

Traumacel ENDO Applicator is a single use, flexible, manual apparatus designed to deliver the absorbable haemostatic powder Traumacel PULVIS.

The main objective of this clinical study is to confirm the safety and efficacy of the medical device Traumacel PULVIS and Traumacel ENDO Applicator when used in accordance with their intended purpose.

The partial objectives are: to identify potential incompatibilities of Traumacel ENDO Applicator with other surgical instruments, in particular with different types of trocar cannulas; for both devices (Traumacel ENDO Applicator and Traumacel PULVIS) the identification and analysis of potential emerging risks; confirmation of the acceptability of the benefit-risk ratio; identification of any systematic misuse of the device or off-label use of the device in order to verify the correctness of its intended purpose.

Study Overview

• Status: Completed
• Conditions: Bleeding; Surgical Wound
• Intervention / Treatment: Device: Traumacel PULVIS, Traumacel ENDO Applicator

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Veronika Sívková; Phone Number: +420 734 310 746; Email: v.sivkova@bioster.cz

Study Locations

• Czechia
  • Hradec Králové, Czechia, 50005
    • University hospital Hradec Králové

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Minimum age of 18.
• Surgical intervention.
• Negative pregnancy test of women in fertile age.
• Diffuse soft tissue, vascular or parenchymal haemorrhage after conventional surgical haemostatic methods have not worked or are impractical (e.g. ligation, suture, compression, cauterisation).
• Informed consent.

Exclusion Criteria:

• Hypersensitivity or a known reaction to oxidized cellulose.
• Age under 18
• A severe clinical condition of the patient (e.g. associated illness, mental disorder) which, according to the investigator, could adversely affect patient safety and/or compliance with the procedures used in the study.
• The patient has participated in another clinical study involving a haemostatic product within 30 days prior to enrolment, or another such clinical study is planned during the subject's participation in the study.
• Pregnancy or lactation.
• If during the procedure itself, there was no need to use the test agent
• Application of any other topical haemostatic product prior to application of the test agent to the same site.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traumacel PULVIS; Traumacel PULVIS will be poured into the bleeding area directly or using an applicator Traumacel ENDO Applicator.	Device: Traumacel PULVIS, Traumacel ENDO Applicator; Haemostatic plant polysaccharide powder made of the oxidized cellulose with flexible applicator (38 cm).; Other Names: Traumastem POWDER, Traumastem ENDO Applicator; EMOXICEL EMIPOL; Traumastem P

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time required to achieve haemostasis	10 minutes
Number of subjects in whom haemostasis was achieved within 3 minutes after administration	3 minutes
Number of subjects who required a surgical revision within 12 hours after the procedure for recurrent bleeding	12 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Degree of bleeding from target bleeding site	10 minutes
Occurrence of adverse events	1 month

Collaborators and Investigators

• Sponsor: Bioster, a.s.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Oxidized cellulose; Haemostatic agent
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: PMCF-29-11-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No