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Completed

NCT Number: NCT05171231

Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery

The aim of this study is to collect performance and safety data relating to the use and the follow-up of the HEMOCOLLAGENE® medical device in routine clinical practice from various hospitals and medical centers in oral dental surgery.

Patients will The data collected from the Post-Market Clinical Follow-up study will be used to support the regulatory requirements of post-market monitoring (risk management, residual risks, instructions for use...) and to increase the manufacturer's clinical data. Patients will be followed for 1 month.

Adverse events (safety) and device performance will be collected by the dentist during the routine follow-up visits.

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Key information

Conditions

Oral Hemorrhage Hemorrhage Mouth Diseases Oral Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cabinet Dento Médical, cabinet de Nivelles, Baulers, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient requiring oral surgery
  • Patient with a bleeding requiring the use of an adjuvant hemostatic
  • Patient implanted with HEMOCOLLAGENE® in dental surgery.
  • Patient who signed his informed consent form

Exclusion criteria

  • Inform Consent not signed
  • Patients with acute oral infection.
  • Patients with an unstable hemodynamic state (acute and/or chronic cardiovascular pathology, low arterial pressure, cardiac rhythm problem)
  • Pregnant and / or breastfeeding patients.
  • Patient with hypersensitivity or allergy to bovine collagen

Treatment and study plan

HEMOCOLLAGENE® : Sterile absorbable hemostatic sponges based on bovine collagen - class III MD

Device

HEMOCOLLAGENE® is an absorbable, sterile and hemostatic sponge, composed of type I undenatured, native and lyophilized bovine collagen (0.027 g per sponge).

HEMOCOLLAGENE® will be inserted into oral sites (mainly the alveoli dental) after post-extraction or post-invasive dental surgical procedure, in case of bleeding not controled by usual hemostatic method. HEMOCOLLAGENE® will be let in place and will undergo a complete and natural absorption after several weeks.

Primary outcomes

  1. Hemostatic Performance at 5 minutes

    Time frame: 5 minutes after treatment onset

    Evaluation of the stop of the bleeding 5 minutes after using HEMOCOLLAGENE®.

Secondary outcomes

  1. Rate of overall adverse events

    Time frame: From treatment onset to 30 days

    overall Safety assessment

  2. Rate of device related adverse events

    Time frame: From treatment onset to 30 days

    Safety assessment relating to the medical device

  3. Wound Healing

    Time frame: At 30 days

    Evaluation of the wound healing using the Landry Score (from "1 - Very Poor" to "5 - Excellent")

  4. Ease of the use of Hemocollagene by the Dentist

    Time frame: At day 0, after using the treatment

    Satisfaction of the dentist on the use and the quality of HEMOCOLLAGENE® :

    • Data relating to the hemostatic agent HEMOCOLLAGENE® (number, reference, quality before and during use).
    • The technique for using HEMOCOLLAGENE® (cutting before or after application, removal or not for hemostasis, fixing).
    • The intraoperative satisfaction of the practitioner.

  5. Rate of hemostatic time at 10 minutes in case persistant bleeding

    Time frame: 10 minutes after treatment onset

    Percentage of patients with a bleeding stopped 10 minutes after treatment onset in case of persistant bleeding

  6. Rate of persistant bleeding

    Time frame: 5 minutes after treatment onset

    Percentage of patients with a bleeding not stopped 5 minutes after treatment onset

Sponsors and collaborators

Lead sponsor

Septodont

Industry

Collaborators

  • EndoData
  • Recherche Clinique en Odontologie (ReCOL)
  • Symatese

Registry information

Official study title

Observational, Multicenter, Prospective Clinical Study, Measuring the Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 28, 2021
Registry last updated
May 6, 2026

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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