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To evaluate the small sample clinical trial of chitosan/polydopamine (CS-PDA) expandable hemostatic sponge for rapid hemostasis of deep wound

Small sample clinical trial of chitosan/polydopamine (CS-PDA) expellable hemostatic sponge for rapid hemostasis of deep wound

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096283
Enrollment
Unknown
Registered
2025-01-21
Start date
2025-01-25
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Emergency bleeding on deep wound

Interventions

experimental group:Chitosan/polydopamine (CS-PDA) expandable hemostatic sponge
control group:Medtronic sponge tamponade to stop bleeding

Sponsors

the Third Hospital Affiliated to Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 30 Years

Inclusion criteria

Inclusion criteria: (1) Patients aged 18-30 years, without gender restriction; (2) Patients diagnosed with mandibular deformity correction, such as mandibular malformation, mandibular forward migration to correct mandibular underdevelopment, or mandibular backward correction of mandibular overdevelopment indications; (3) Sign informed consent to understand the operation process, risks and postoperative care; (4) There are no contraindications to surgery and anesthesia drugs, and the physical examination results meet the requirements of surgery and general anesthesia; (5) Patient data should be complete for comparative analysis and evaluation before and after surgery;

Exclusion criteria

Exclusion criteria: (1) Patients with poorly controlled diabetes (drug controlled fasting blood glucose >=7.0mmol/L, or random blood glucose >=11.1mmol/L, or HbA1c >=6.5%); (2) Patients with a history of genetic diseases such as congenital syndromes that cause asymmetrical facial development; (3) Patients with a history of orthognathic surgery and temporomandibular joint disease; (4) Patients with a history of maxillary or mandibular trauma; (5) Patients with substance abuse and poor mental status; (6) Have participated in clinical trials of other drugs or medical devices within the last 3 months; (7) Patients with abnormal coagulation function or history of coagulation disorder (prothrombin time (PT), activated partial thromboplastin time (APTT)), international standardized ratio (INR), fibrin (FIB)); (8) Those who have taken anticoagulant drugs or other drugs that have an effect on the blood system within the past 14 days; Abnormal liver and kidney function (ALT, AST more than 3 times the normal value; (Creatinine and urea nitrogen/urea exceed the normal range); (9) Patients with severe heart disease (i.e., those with New York Heart Function Scale (NYHA) levels II and above), and those who do not respond to treatment and care programs; (10) Women who are pregnant, breastfeeding or planning to become pregnant within the next 3 months; (11) Other conditions in which the physician determines that the patient cannot participate in the clinical trial (patients with missing imaging data or missing follow-up).

Design outcomes

Primary

MeasureTime frame
Hemostasis time of mandibular sagittal split operation site;

Secondary

MeasureTime frame
Bone healing rate and time after surgery;Test quality control;

Countries

China

Contacts

Public ContactBaolin Guo,Yimin Zhao,Lei Tian

Xi 'an Jiaotong University, the Third Affiliated Hospital of Air Force Medical University

baoling@mail.xjtu.edu.cn+86 180 9213 9381

Outcome results

None listed

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