Health TrialsbyHealthPanel

Absorbable Hemostatic Fluid Gelatin Trial

ConditionSurgical Bleeding
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedprin Regenerative Medical Technologies Co., Ltd.

About this 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

324 Participants
are divided into 2 treatment groups
Group A: Absorbable Hemostatic Fluid GelatinExperimental treatment 1 intervention
Group B: SURGIFLO™ Hemostatic MatrixActive comparator 1 intervention

Trial outcomes

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

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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medprin Regenerative Medical Technologies Co., Ltd.

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Collaborator

Southern Medical University, China

Collaborator

Xi'an Honghui Hospital

Collaborator

The Third Affiliated Hospital of Southern Medical University

Collaborator

Obstetrics & Gynecology Hospital of Fudan University

Collaborator

Zhejiang Provincial People's Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: