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

NCT05177887 | Completed

• 1 other identifier: PMCF-29-11-20
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bleeding; Surgical Wound

Keywords

Oxidized cellulose; Haemostatic agent

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Degree of bleeding from target bleeding site

  10 minutes

• Occurrence of adverse events

  1 month

Study Arms (1)

Traumacel PULVIS

EXPERIMENTAL

Traumacel PULVIS will be poured into the bleeding area directly or using an applicator Traumacel ENDO Applicator.

Device: Traumacel PULVIS, Traumacel ENDO Applicator

Interventions

Traumacel PULVIS, Traumacel ENDO Applicator DEVICE

Haemostatic plant polysaccharide powder made of the oxidized cellulose with flexible applicator (38 cm).

Also known as: Traumastem POWDER, Traumastem ENDO Applicator, EMOXICEL EMIPOL, Traumastem P

Traumacel PULVIS

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioster, a.s.: lead

Study Sites (1)

University Hospital Hradec Králové

Hradec Králové, 50005, Czechia

Location

MeSH Terms

Conditions

Hemorrhage; Surgical Wound

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 5, 2022
• Study Start: February 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)