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Randomized, controlled, prospective trial to evaluate the safety and effectiveness of shataqi soluble gauze in surgery

Randomized, controlled, prospective trial to evaluate the safety and effectiveness of shataqi soluble gauze in surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001427
Enrollment
Unknown
Registered
2011-07-14
Start date
2011-06-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bleeding during the surgery

Interventions

A:Shatiaqi Soluble Gauze
B:Tailing Soluble Gauze

Sponsors

Nanfang Hospital of Nanfang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. At least 18 years and less than 65 years old; 2. Properative diagnosed with right colon cancer or gastric cancer who would be treated with right hemicolectomy or D2 radical gastrectomy respectively; 3. There was significant bleeding either in the right colon cuts within the right hemicolectomy or superior pancreas cut within the D2 radical gastrectomy and consequently decided by the investigator to apply the hemostatic gauze; 4. The patient or patient's legally-authorized representative agrees to participate in this study by signing the Ethics Committee (EC)-approved ICF prior to procedure.

Exclusion criteria

Exclusion criteria: 1. Emergency surgery, parenchyma or anastomotic bleeding Active bleeding during the surgery; 2. Serious bleeding-related complications or in any case that investigator decided not to cintunue the study Could not tolerate or refuse blood products or whole blood transfusion; 3. Known or suspected to be allergic to the product orany ingredient (eg, human collagen, fibrinogen, etc.); 4. Coagulation disorders or autoimmune deficiencies; 5. Alcohol or drug abuse; 6. Systemic factors are not conducive to surgery, such as sepsis, or there is any type of serious infectious diseases a month ago before surgery, disseminated intravascular coagulation (dic), or the extensive microvascular bleeding; 7. Suffered from cancer, whose lives are expected less than 3 years. Pregnant or nursing; 8. Another investigational drug or device within 30days patients are poor in compliance and could not complete the follow up as required.

Design outcomes

Primary

MeasureTime frame
Success of hemostasia in 5 minute;Success of hemostasia in 3 minut;

Secondary

MeasureTime frame
Success of hemostasia in 10 minut;

Countries

China

Contacts

Public ContactGuoxin Li
gzliguoxin@163.com+86 20 61641682

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026