A Phase 3 interventional study of Absorbable Multilayer Fibrillar Regenerated Oxidized Cellulose and SURGICEL Absorbable Hemostat (Absorbable Hemostatic Gauze) in Surgical Bleeding, Hemorrhage and Oxidized Regenerated Cellulose, sponsored by Medprin Regenerative Medical Technologies Co., Ltd.. Completed at 6 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Medprin Regenerative Medical Technologies Co., Ltd. · Phase 3, Interventional, and Treatment
This is a multicenter, randomized, single-blind, positive-controlled, non-inferiority clinical trial. The purpose is to evaluate the safety and effectiveness of the absorbable multilayer fibrillar regenerated oxidized cellulose in controlling capillary, venous, and small arteriole bleeding during surgical procedures when ligation or other conventional methods are ineffective or impractical. A total of 288 subjects (144 in the test group, 144 in the control group) will be enrolled across 6 centers (General Surgery, Cardiothoracic Surgery, Gynecology, and Urology). Subjects will be followed up at 30±15 days and 180±30 days post-surgery. The primary efficacy endpoint is the hemostasis success rate within 5 minutes.
1,383 studies on the registry are indexed under Hemorrhage; 244 are open to participants now.
This study's enrollment of 288 is above the median of 102 across 926 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →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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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 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.
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects undergoing surgical procedures (including general surgery, cardiothoracic surgery, gynecology, and urology) who require adjunctive hemostasis for capillary, venous, and small arteriole bleeding when ligation or other conventional methods are ineffective or impractical. The test device is applied to the Target Bleeding Site (TBS) as an adjunctive hemostatic agent.
Device: Absorbable Multilayer Fibrillar Regenerated Oxidized Cellulose
Subjects undergoing surgical procedures (including general surgery, cardiothoracic surgery, gynecology, and urology) who require adjunctive hemostasis for capillary, venous, and small arteriole bleeding when ligation or other conventional methods are ineffective or impractical. The control device is applied to the Target Bleeding Site (TBS) as an adjunctive hemostatic agent per its approved labeling.
Device: SURGICEL Absorbable Hemostat (Absorbable Hemostatic Gauze)
A sterile, absorbable, multilayer fibrillar regenerated oxidized cellulose dressing intended for use as an adjunctive hemostatic agent to control capillary, venous, and small arteriole bleeding during surgical procedures. The product is applied directly to the bleeding site and can be layered as needed. It is absorbed in the body over time.
A sterile, absorbable oxidized regenerated cellulose hemostatic dressing indicated for use as an adjunctive hemostatic agent to control capillary, venous, and small arteriole bleeding during surgical procedures. The product is applied directly to the bleeding site and is absorbed in the body.
Hemostasis Success Rate within 5 Minutes
Success is defined as the cessation of bleeding (no persistent oozing from the target bleeding site, TBS) within 5 minutes from the time the product is fully applied to the TBS. Failure is defined as bleeding lasting \>5 minutes.
Time frame: Intraoperative (Day of surgery)
Time to Hemostasis
Time measured from product application to the complete cessation of bleeding at the TBS.
Time frame: Intraoperative (Day of surgery)
Device Usability Evaluation
Evaluation of ease of use in endoscopic/laparoscopic procedures, adhesion to instruments, fit to the wound surface, and ease of layering.
Time frame: Intraoperative (Day of surgery)
Incidence of Adverse Events and Device-related Adverse Events
Incidence of Adverse Events and Device-related Adverse Events
Time frame: Through study completion (up to 180±30 days post-surgery)
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2022 to primary completion in Jan 2024, 14 months.
Of 71 phase 3 interventional studies under Hemorrhage, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 65. This study's 14 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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