A Trial of Absorbable Regenerated Oxidized Cellulose for Surgical Hemostasis)

NCT07764055 | Completed Phase 3

• 1 other identifier: MP-CTP-ZXS2022
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Surgical Bleeding; Hemorrhage; Oxidized Regenerated Cellulose

Keywords

Absorbable hemostatic material; Oxidized regenerated cellulose; Surgical hemostasis; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Intraoperative (Day of surgery)

Secondary Outcomes (2)

• Time to Hemostasis

  Intraoperative (Day of surgery)

• Device Usability Evaluation

  Intraoperative (Day of surgery)

Other Outcomes (1)

• Incidence of Adverse Events and Device-related Adverse Events

  Through study completion (up to 180±30 days post-surgery)

Study Arms (2)

Experimental: Absorbable Multilayer Fibrillar Regenerated Oxidized Cellulose

EXPERIMENTAL

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

Active Comparator: SURGICEL Absorbable Hemostat

ACTIVE COMPARATOR

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)

Interventions

Absorbable Multilayer Fibrillar Regenerated Oxidized Cellulose DEVICE

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.

Experimental: Absorbable Multilayer Fibrillar Regenerated Oxidized Cellulose

SURGICEL Absorbable Hemostat (Absorbable Hemostatic Gauze) DEVICE

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.

Active Comparator: SURGICEL Absorbable Hemostat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, any gender.
• Patients scheduled for surgical procedures where adjunctive hemostasis is anticipated.
• Patient and/or legal guardian has provided written informed consent.

You may not qualify if:

• Participated in another clinical trial within 1 month prior to surgery.
• Presence of acute infection.
• Severe diseases of vital organs (heart, liver, kidney) or hematological diseases that would make the patient intolerant to surgery.
• Known allergy to regenerated oxidized cellulose.
• History of severe allergies or severe immunodeficiency.
• Severe coagulation dysfunction (e.g., platelet count \< 50×10\^9/L, INR \> 2).
• Life expectancy \< 6 months.
• Pregnant or breastfeeding women.
• Patients deemed non-compliant or unable to complete the study as judged by the investigator.
• Unable to understand the study description provided by the investigator.
• Any other condition deemed unsuitable for participation by the investigator (e.g., extensive trauma, extremely unstable vital signs, life-threatening massive bleeding).

Sponsors & Collaborators

• Medprin Regenerative Medical Technologies Co., Ltd.: lead
• Sir Run Run Shaw Hospital: collaborator
• Tongji Hospital, Tongji Medical College, HUST: collaborator
• Zhejiang Provincial People's Hospital: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (6)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, China

Location

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 13, 2026
• Study Start: November 9, 2022
• Primary Completion: January 15, 2024
• Study Completion: March 5, 2024
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)