Health Condition 1: null- TRAUMA PATIENTS WITH RAW AREAS ON DONOR GRAFT SITE
Conditions
Interventions
Intervention1: fibroheal (natural product obtained from centellaasiatica herbal wound healing sheet: fibroheal (natural product obtained from centellaasiatica herbal wound healing sheet will be applie
Sponsors
SericareDivision of Healthline Pvt Ltd Funded by SIBRI DBT
SIBRI DIVISION OF DEPTT OF BIOTECHNOLOGY
Eligibility
Inclusion criteria
Inclusion criteria: Subjects to be included in the study must meet the following eligibility criteria: 1. Age: 18 -55 years 2. Subjects with wounds caused by trauma / burns, donor site grafts 3. Wound size at least 10 cm x 10 cm; depth 0.15 -0.45 mm (0.006-0.018 inches) 4. Eligible to receive dressing on an inpatient basis for 2 weeks and on outpatient basis for 2 weeks. 5. Not currently on any other interventional treatment. 6. The subject and /or guardian are able understand instructions and are willing to give written informed consent and comply with the requirements of the study protocol. 7. The subject is willing to complete all follow-up evaluations required by the study protocol 8. Subjects non-allergic to the investigational product 9. The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary 10. The subject agrees to abstain from enrollment in any other clinical trial for the duration of the study
Exclusion criteria
Exclusion criteria: 1. History of or current other inflammatory diseases 2. Infection, allergy on the tested area. 3. Chronic wound showing signs of infections with copious slough and purulent discharge 4. Subject on topical medication for wound less than 1 week. 5. Cutaneous disease which may influence the study result. 6. Chronic illness which may influence the cutaneous state. 7. Subject on oral corticosteroid with dose > 10mg/day. 8. Subject participated in other cosmetic or therapeutic trial less than 4 weeks ago. 9. Any underlying medical illness including, liver disease or history of alcoholism, HIV or any other serious medical illness. 10. Pregnant and lactating women 11. Donor sites other than the thigh
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the efficacy of Fibroheal in the treatment of split- thickness skin graft donor sites and partial thickness wounds caused by TRAUMA/burns in relation to healing time and scar formation. Timepoint: To demonstrate the efficacy of Fibroheal in the treatment of split- thickness skin graft donor sites and partial thickness wounds caused by TRAUMA/burns in relation to healing and scar formation at 1,2,4, 6 weeks interval. | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate safety of fibroheal in the treatment of graft donor site dressingTimepoint: 3months follow up | — |
Countries
India
Contacts
Public ContactDr Sushma Sagar
AIIMS DELHI
Outcome results
None listed