Complex and difficult to heal wounds
Conditions
Interventions
experimental group :recombinant human collagen hydrogel
Sponsors
Department of Burns, First Affiliated Hospital of Naval Medical University (formerly Department of Burns, Shanghai Changhai Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: (1) 18 to 90 years old, no gender limit; (2) Target wound area = 2 times or continuous regular treatment cycle >= 8 weeks, the effect is not satisfactory; d) Clinically diagnosed as radiation ulcer, surgical history >= 2 times or continuous regular treatment cycle >= 8 weeks, the effect is not satisfactory; e) Recurrent ulceration in the early stage of wound healing or after scar formation, history of surgery >= 2 times or continuous regular treatment cycle >= 8 weeks, with unsatisfactory results; f) Bone exposure and tendon exposure caused by various reasons, the exposed short diameter is = 4 weeks of wounds, patients who cannot tolerate surgery and only need palliative treatment; i) Patients with residual wounds after clinical diagnosis of large burns (burn area >= 30% TBSA, or skin graft area >= 10% TBSA), lack of skin source or surgical intolerance; (4) Those who agree to participate in this study and sign a written informed consent.
Exclusion criteria
Exclusion criteria: (1) Severe malnutrition, albumin 38.5 degrees or white blood cell > 12 x 10^9/L or wound edge swelling > 5cm; (3) Multi-drug resistant bacteria infections that are difficult to control or severe systemic infections; (4) Those who are known to have a history of allergies or allergies (allergic to 2 or more allergens) to the ingredients or other chemical structures contained in this product and the reference substance; (5) Pregnant or breast-feeding women and those who have a childbirth plan within the past 6 months; (6) Those who have participated in other clinical research within 1 month before being selected; (7) There are situations in which other researchers think it is inappropriate to participate in clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficiency;Wound reduction rate in the second week of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Countries
China
Contacts
Public ContactZhu Shihui
Department of Burns, First Affiliated Hospital of Naval Medical University (formerly Department of Burns, Shanghai Changhai Hospital)
Outcome results
None listed