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Completed

NCT Number: NCT05177874

Traumacel FAM Trium in the Post-market Surveillance Phase

The investigational medical device Traumacel FAM Trium is a sterile plant polysaccharide haemostatic agent based on the oxidized cellulose in the form of multilayer nonwoven fabric. It is used as an adjunct to stop capillary, venous, or small arterial bleeding, and also to prevent early postoperative bleeding. It can be used in all areas of stopping diffuse bleeding from resection surfaces such as parenchymatous organs, muscles or defined body cavities. The wide scope of application allows the use for classical, robotic surgery and endoscopic treatments (e.g. laparoscopic).

The main objective of the study is to compare the efficacy and safety of Traumacel FAM Trium and regenerated oxidized cellulose based fibrous haemostat when used in accordance with their intended purpose. The partial objectives are: identification of any previously unknown side-effects and monitoring of known side-effects; identification and analysis of potentially newly 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 FAM Trium

Device

Absorbable Hemostat (oxidized non-regenerated cellulose)

Other names: Traumastem FAM Trium, EMOXICEL FAM Trium, Traumastem Fibrillar, Celstat Fibrillar

Surgicel Fibrillar

Device

Absorbable Hemostat (oxidized regenerated cellulose)

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 surgical revision within 12 hours after the procedure for recurrent bleeding.

    Time frame: 12 hours

Secondary outcomes

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

    Time frame: 2 minutes

  2. Degree of bleeding from target bleeding site

    Time frame: 10 minutes

  3. Number of subjects with complications during surgery.

    Time frame: During a surgical procedure, an average of 1 hour

  4. Occurrence of adverse events.

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Bioster, a.s.

Industry

Registry information

Official study title

Multicentric, Prospective, Controlled, Randomised Clinical Study of the Device Traumacel FAM Trium in the Post-market Surveillance Phase

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2022
Registry last updated
Jan 5, 2022

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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