A Phase 3 interventional study of Absorbable Hemostatic Fluid Gelatin and Absorbable Hemostatic Fluid Gelatin SURGIFLO Haemostatic Matrix in Surgical Bleeding, sponsored by Medprin Regenerative Medical Technologies Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Medprin Regenerative Medical Technologies Co., Ltd. · Phase 3, Interventional, and Treatment
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).
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.
Medprin Regenerative Medical Technologies Co., Ltd. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Absorbable Hemostatic Fluid Gelatin
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
Device: Absorbable Hemostatic Fluid Gelatin SURGIFLO Haemostatic Matrix
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.
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
5-Minute Hemostasis Success Rate
Time frame: Intraoperative (Day of surgery)
3-Minute Hemostasis Success Rate
Time frame: Intraoperative (Day of surgery)
Wound Hemostasis Time (T)
Time frame: Intraoperative (Day of surgery)
Total Postoperative Drainage Volume
Time frame: Perioperative period (time from end of surgery to patient's removal of drainage tube)
Device Usability Evaluation
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.
Time frame: Intraoperative (Day of surgery)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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