Health Condition 1: T758- Other specified effects of external causes
Conditions
Interventions
Intervention1: Poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV) nanofibrous synthetic biodegradable skin graft for full-thickness wounds: The objective of the study is to investigate the safety and
Sponsors
SASTRA Deemed University
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males / females 18 or older 2. Patients with full-thickness traumatic wounds, surgical wounds, diabetic wounds, post-debridement wounds of 1 to 10 cm 2 3. Ulcer free of all necrotic and infected soft tissue (based on clinical investigatorâ??s discretion). 4. Have no significant diseases or clinically significant abnormal laboratory values during screening 5. In case of diabetic subjects, with regular medical treatment for diabetes 6. Able to understand, communicate and sign the written informed consent form 7. Adequate hematology, biochemistry & urine laboratory values
Exclusion criteria
Exclusion criteria: Any of the following is regarded as a criterion for exclusion from the study: 1. Patients showing impaired blood coagulation 2. Patients with hematopoietic, renal, immunological and dermatological diseases/disorders 3. History of psychiatric disorders 4. Recent history ( 5. Smokers, who smoke more than 10 cigarettes per day and cannot refrain from smoking during the study period 6. Use of any recreational drugs or a history of drug addiction 7. Participation in another trial within 30 days of enrollment for this study 8. Women who are pregnant or are breast feeding 9. Subjects with positive HIV, HBV and HCV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency and severity of all treatment-related adverse events, during and after use of PHBV nanofibrous scaffold will be examined throughout the follow-up period. Adverse events will be assessed on a continuous basisTimepoint: 1 week, 2 weeks, 3 weeks, 4, weeks, 5 weeks and 6 weeks post-implantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound closureTimepoint: The treatment period of each subject will be 6 weeks and follow up period of 5 weeks | — |
Countries
India
Contacts
Public ContactDr Binita Beck
SASTRA Deemed University
Outcome results
None listed