â??multicentric, open-label, safety and efficacy study of Fibroheal® (CentellaAsiatica herbal wound healing sheet) in split- thickness skin graft donor sitetreatment and partial thickness wounds caused by Trauma/burns.

Phase 4

• Conditions: Health Condition 1: null- TRAUMA PATIENTS WITH RAW AREAS ON DONOR GRAFT SITE

• Registration Number: CTRI/2014/07/004732
• Lead Sponsor: SericareDivision of Healthline Pvt Ltd Funded by SIBRI DBT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 12

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified