Hemorrhage, Oxidized Regenerated Cellulose, Surgical Bleeding
Conditions
Keywords
Absorbable hemostatic material, Oxidized regenerated cellulose, Surgical hemostasis, Randomized controlled trial
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.
Interventions
DEVICEAbsorbable Multilayer Fibrillar Regenerated Oxidized Cellulose
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.
DEVICESURGICEL 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.
Sponsors
Medprin Regenerative Medical Technologies Co., Ltd.
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 design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis Success Rate within 5 Minutes | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to Hemostasis | Intraoperative (Day of surgery) | Time measured from product application to the complete cessation of bleeding at the TBS. |
| Device Usability Evaluation | 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. |
Countries
China
Outcome results
None listed