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Safety Effectiveness Study of Collagen Wound Dressing (Fulean) for Protecting Promoting Surgical Wound Healing

Safety Effectiveness Study of Collagen Wound Dressing (Fulean) for Protecting Promoting Surgical Wound Healing

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-15007071
Enrollment
Unknown
Registered
2015-09-11
Start date
2015-09-30
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

Surgical wound

Interventions

Control:Collagen Sponge
Test:Collagen Wound Dressing (Fulean)

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age >= eighteen, no restricted about sex; Abdominal surgical wound, class I or II; Subject or legal representative is able to understthe purpose of this study, compliance to the study sign the clinical consent.

Exclusion criteria

Exclusion criteria: The wound is greater than ten cm; non-stage I suture surgical wound and/or the time of drainage is longer than fourty-eight hrs; the wound has large amount of exudate; random blood glucose before surgery >ten mmol/L; subject has moderate mulnutrition (BMI<seventeen kg/m2) and/or severe anemia (Hb<sixty g/L); any dermatosis near to the surgical wound will have a negative effect to the healing of the wound; subject is prescribing immunosuppresnt or steroid; severe bleeding tendency coagulation disorder patients or patients under anti-coagulation treatment; allergy or sensitiveness to porcine ox collagen; pregnancy lactating women; participated to other drug or medical device clinical researches in the last three months; Any other situations will affect study results of PI consideration.

Design outcomes

Primary

MeasureTime frame
incidence of wound healing at the first grade;

Secondary

MeasureTime frame
time of wound healing at the first grade;incidence of surgical site superfacial tissue infection at the first 3 days;

Countries

China

Contacts

Public ContactHuang Feizhou
Huangfeizhou@medmail.com+86 18975186183

Outcome results

None listed

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