None listed
Conditions
Interventions
Intervention1: Poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV): PHBV nanofibrous mat of 0.2 mm thick would be applied to the full-thickness wounds as a dermal substitute. This is just a surface ap
Sponsors
SASTRA University and Department of Science Technology New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Males and females between 18 or older will: • be informed of the nature of the study and will give written informed consent • have body weights within 25% of the appropriate weight range, • have 12 lead ECG without significant abnormalities, • be on no regular medical treatment for wound healing/ diabetic wound healing or as at the description of the dermatologist • be able to communicate effectively with study personnel
Exclusion criteria
Exclusion criteria: • Any disease or condition which might compromise the haematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system. • History of allergic conditions â?? asthma, urticaria, eczema. • History of autoimmune disorders â?? lupus erythematosis (SLE) • History or presence of dyspepsia, gastric ulcer or duodenal ulcer. • History of psychiatric disorders. • Recent history of alcoholism ( • Smokers, who smoke more than 10 cigarettes per day and canâ??t refrain from smoking during the study period. • Presence of clinically significant abnormal laboratory results during screening. Use of any recreational drugs or a history of drug addiction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound healingTimepoint: 1 and 2 weeks post application of graft | — |
Secondary
| Measure | Time frame |
|---|---|
| Re-epithelializationTimepoint: 3 and 4 weeks post application of graft | — |
Countries
India
Contacts
Public ContactG Ravikumar
Thanjavur Medical College
Outcome results
None listed