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

Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05177887
• Other study ID #: PMCF-29-11-20
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: July 2023
• Source: Bioster, a.s.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bleeding
• Surgical Wound

Intervention

Device:
• Traumacel PULVIS, Traumacel ENDO Applicator
Haemostatic plant polysaccharide powder made of the oxidized cellulose with flexible applicator (38 cm).

Locations

Country	Name	City	State
Czechia	University Hospital Hradec Králové	Hradec Králové

Sponsors (1)

Lead Sponsor	Collaborator
Bioster, a.s.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time required to achieve haemostasis		10 minutes
Primary	Number of subjects in whom haemostasis was achieved within 3 minutes after administration		3 minutes
Primary	Number of subjects who required a surgical revision within 12 hours after the procedure for recurrent bleeding		12 hours
Secondary	Degree of bleeding from target bleeding site		10 minutes
Secondary	Occurrence of adverse events		1 month