Surgical BleedingPhase 3ZXS2022NCT07764055

A Trial of Absorbable Regenerated Oxidized Cellulose for Surgical Hemostasis)

A Phase 3 study testing Absorbable Multilayer Fibrillar Regenerated Oxidized Cellulose and SURGICEL Absorbable Hemostat (Absorbable Hemostatic Gauze) in people with Surgical Bleeding and Hemorrhage, run by Medprin Regenerative Medical Technologies Co., Ltd. at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Surgical Bleeding, Hemorrhage, Oxidized Regenerated Cellulose
What is being tested?: Absorbable Multilayer Fibrillar Regenerated Oxidized Cellulose and SURGICEL Absorbable Hemostat (Absorbable Hemostatic Gauze)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 288 participants
Where: 6 sitesChina
Study dates: 9 Nov 2022to 5 Mar 2024
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

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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).

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

China6 sites

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou
Zhejiang Provincial People's Hospital
Hangzhou
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan

Other trials in China

About this study

Official title: A Multicenter, Randomized, Single-Blind, Positive-Controlled Clinical Trial of Absorbable Multilayer Fibrillar 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.

Conditions: Surgical Bleeding, Hemorrhage, Oxidized Regenerated Cellulose
Being tested: Absorbable Multilayer Fibrillar Regenerated Oxidized Cellulose, SURGICEL Absorbable Hemostat (Absorbable Hemostatic Gauze)
Keywords: Absorbable hemostatic material, Oxidized regenerated cellulose, Surgical hemostasis, Randomized controlled trial
Medical subject headings: Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Absorbable Multilayer Fibrillar Regenerated Oxidized CelluloseDevice
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.

Study groups in NCT07764055
Study group	Role	What they receive
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. Receives: 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. Receives: Device: SURGICEL Absorbable Hemostat (Absorbable Hemostatic Gauze)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Intraoperative (Day of surgery)

Secondary outcomes (2)

Time to Hemostasis
Time measured from product application to the complete cessation of bleeding at the TBS.
Measured: 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.
Measured: Intraoperative (Day of surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Nov 20225 Mar 2024

First posted13 Aug 2026
Study start9 Nov 2022
Primary completion15 Jan 2024
Study completion5 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Surgical BleedingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 288 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07764055
Sponsor's protocol ID: MP-CTP-ZXS2022
Acronym: ZXS2022
Status last verified: Aug 2026
First submitted: 9 Aug 2026
Last updated: 13 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Surgical Bleeding trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Single-Blind, Positive-Controlled Clinical Trial of Absorbable Multilayer Fibrillar Regenerated Oxidized Cellulose for Surgical Hemostasis
ClinicalTrials.gov ID: NCT07764055
Acronym / sponsor ID: ZXS2022 / MP-CTP-ZXS2022
Conditions: Surgical Bleeding, Hemorrhage, Oxidized Regenerated Cellulose
Keywords: Absorbable hemostatic material, Oxidized regenerated cellulose, Surgical hemostasis, Randomized controlled trial
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 288 participants (actual)
Lead sponsor: Medprin Regenerative Medical Technologies Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Sir Run Run Shaw Hospital, Tongji Hospital, Tongji Medical College, HUST, Zhejiang Provincial People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital of Guangzhou Medical University
Study start: 9 Nov 2022 (actual)
Primary completion: 15 Jan 2024 (actual)
Study completion: 5 Mar 2024 (actual)
First posted: 13 Aug 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Experimental: Absorbable Multilayer Fibrillar Regenerated Oxidized Cellulose	Experimental	Device: Absorbable Multilayer Fibrillar Regenerated Oxidized CelluloseSubjects 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.
Active Comparator: SURGICEL Absorbable Hemostat	Active comparator	Device: SURGICEL Absorbable Hemostat (Absorbable Hemostatic Gauze)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Absorbable Multilayer Fibrillar Regenerated Oxidized CelluloseA 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.	Device	Experimental: Absorbable Multilayer Fibrillar Regenerated Oxidized Cellulose
SURGICEL Absorbable Hemostat (Absorbable Hemostatic Gauze)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.	Device	Active Comparator: SURGICEL Absorbable Hemostat

Primary outcome

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.

2 secondary outcomes

Time to Hemostasis
Time frame: Intraoperative (Day of surgery)
Device Usability Evaluation
Time frame: Intraoperative (Day of surgery)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
Individual participant dataSharing planned: No

Related trials for Surgical Bleeding

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemostasis Success Rate within 5 Minutes (time frame: Intraoperative (Day of surgery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07764055.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.