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Completed

NCT Number: NCT05177887

Traumacel PULVIS and 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.

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Key information

Conditions

Bleeding Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Surgical Wound Wounds and Injuries

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Hradec Králové

Hradec Králové, 50005, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Traumacel PULVIS, Traumacel ENDO Applicator

Device

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

Primary outcomes

  1. Time required to achieve haemostasis

    Time frame: 10 minutes

  2. Number of subjects in whom haemostasis was achieved within 3 minutes after administration

    Time frame: 3 minutes

  3. Number of subjects who required a surgical revision within 12 hours after the procedure for recurrent bleeding

    Time frame: 12 hours

Secondary outcomes

  1. Degree of bleeding from target bleeding site

    Time frame: 10 minutes

  2. Occurrence of adverse events

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Bioster, a.s.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2022
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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