Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07830797

Absorbable Hemostatic Fluid Gelatin Trial

This is a multicenter, single-blind, randomized controlled, non-inferiority trial evaluating the safety and efficacy of an absorbable hemostatic fluid gelatin for surgical hemostasis. Subjects are patients undergoing elective/semi-elective surgeries in General Surgery, Orthopedics, and Gynecology. The test group receives the investigational device, while the control group receives a marketed predicate device (SURGIFLO). The primary outcome is the 5-minute hemostasis success rate at the Target Bleeding Site (TBS).

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Surgical Bleeding

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

This trial enrolls 324 participants (162 per group) across General Surgery, Orthopedics, and Gynecology, with equal allocation per specialty (108 each). Each subject has one Target Bleeding Site (TBS). After conventional hemostasis fails or is not applicable, subjects are randomized to receive either the test or control device. Time from product application (T0) to hemostasis (TF) is recorded. Postoperative follow-up extends to 4 months, assessing adverse events, drainage volume, and laboratory changes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1. Age ≥18 years;
  • 2. Scheduled for elective/semi-elective surgery in General Surgery, Orthopedics, or Gynecology;
  • 3. Signed informed consent. (Intra-op): 1. Presence of a suitable Target Bleeding Site (TBS).

Exclusion criteria

  • 1. Allergy to porcine gelatin or refusal of porcine-derived products;
  • 2. INR>1.5 or PLT<100×10⁹/L;
  • 3. Severe hepatic/renal dysfunction;
  • 4. Pregnancy/lactation;
  • 5. Participation in another trial within 30 days;
  • 6. Unsuitable per investigator.

Treatment and study plan

Absorbable Hemostatic Fluid Gelatin

Device

Composed of fluid gelatin preloaded in a syringe with catheter components; gelatin derived from porcine skin. Applied to TBS and covered with moist gauze during surgery.

Absorbable Hemostatic Fluid Gelatin SURGIFLO Haemostatic Matrix

Device

This product is a flowable hemostatic material made from a porcine skin-derived gelatin matrix, intended to control bleeding from capillaries, veins, and small arteries during surgical procedures

Primary outcomes

  1. 5-Minute Hemostasis Success Rate

    Time frame: Intraoperative (Day of surgery)

Secondary outcomes

  1. 3-Minute Hemostasis Success Rate

    Time frame: Intraoperative (Day of surgery)

  2. Wound Hemostasis Time (T)

    Time frame: Intraoperative (Day of surgery)

  3. Total Postoperative Drainage Volume

    Time frame: Perioperative period (time from end of surgery to patient's removal of drainage tube)

  4. Device Usability Evaluation

    Time frame: Intraoperative (Day of surgery)

    Evaluate device usability on the day of surgery. Evaluation items include: 1. Convenience of device assembly; 2. Convenience of product use; 3. Wound adhesion quality; 4. Wound applicability (evaluating applicability across different wound types, such as diffuse bleeding wounds, irregular wounds, and deep cavity wounds, etc.). A 1-5 scoring scale is used: 5=Excellent, 4=Good, 3=Fair, 2=Poor, 1=Very Poor/Unacceptable. Items scoring <3 (Poor, Very Poor, Unacceptable) require special attention, and the reasons must be documented.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuchuan Zhang

CONTACT

[email protected]

+86 18666661546

Sponsors and collaborators

Lead sponsor

Medprin Regenerative Medical Technologies Co., Ltd.

Industry

Collaborators

  • Obstetrics & Gynecology Hospital of Fudan University
  • Southern Medical University, China
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • The Third Affiliated Hospital of Southern Medical University
  • Xi'an Honghui Hospital
  • Zhejiang Provincial People's Hospital

Registry information

Official study title

A Multicenter, Single-Blind, Randomized Controlled Clinical Trial of the Safety and Efficacy of Absorbable Hemostatic Fluid Gelatin for Surgical Hemostasis

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 21, 2026
Registry last updated
Sep 21, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.