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NCT Number: NCT07764055

A Trial of Absorbable Regenerated Oxidized Cellulose for Surgical Hemostasis)

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.

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Key information

Conditions

Surgical Bleeding Hemorrhage Oxidized Regenerated Cellulose Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Hemostasis Success Rate within 5 Minutes

    Time frame: Intraoperative (Day of surgery)

    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.

Secondary outcomes

  1. Time to Hemostasis

    Time frame: Intraoperative (Day of surgery)

    Time measured from product application to the complete cessation of bleeding at the TBS.

  2. Device Usability Evaluation

    Time frame: Intraoperative (Day of surgery)

    Evaluation of ease of use in endoscopic/laparoscopic procedures, adhesion to instruments, fit to the wound surface, and ease of layering.

Other outcomes

  1. Incidence of Adverse Events and Device-related Adverse Events

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

    Incidence of Adverse Events and Device-related Adverse Events

Sponsors and collaborators

Lead sponsor

Medprin Regenerative Medical Technologies Co., Ltd.

Industry

Collaborators

  • Sir Run Run Shaw Hospital
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • The First Affiliated Hospital of Guangzhou Medical University
  • Tongji Hospital, Tongji Medical College, HUST
  • Zhejiang Provincial People's Hospital

Registry information

Official study title

A Multicenter, Randomized, Single-Blind, Positive-Controlled Clinical Trial of Absorbable Multilayer Fibrillar Regenerated Oxidized Cellulose for Surgical Hemostasis

Acronym: ZXS2022

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 13, 2026
Registry last updated
Aug 13, 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.

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