Study of C1 Herbal oil healing properties in skin wounds

Phase 2

• Conditions: Health Condition 1: null- Patients having Superficial external wounds and Split thickness skin graft (STSG) donor sites

• Registration Number: CTRI/2017/10/010150
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

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: 30

Inclusion Criteria

Patients with wounds requiring STSG cover

Exclusion Criteria

1. Known allergy/hypersensitivity to any of the components of the dressing

2. Fracture/DVT of lower extremity

3. A skin disorder that is chronic or currently active

4. Polytrauma patients

5. Wound at the surgical site prior to surgery

6. Neurological deficit at wound site (Hemiplegia etc.)

7. Haemoglobin level < 7.0 g/dl

8. Serum Albumin <3 g/dl

9. Subjects who, in the opinion of investigator, may not complete the study for any reason

10. Hepatic failure, renal failure, coagulopathy, known cases of Diabetes mellitus

11. Immunocompromised patients such as with Acquired immunodeficiency syndrome or receiving systemic immune suppression

12. Patients who have psychiatric disorders or physical disabilities that hinders the study

13. Pregnancy or Lactation

14. Patient has history of poor wound healing, history of smoking/drug/alcohol abuse

15. Poor prognosis patients unlikely to survive the trial period

16. Patients where a reference wound cannot be treated in isolation from other wounds

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Time to complete re-epithelisation <br/ ><br>2. Incidence of Wound infection <br/ ><br>3. Incidence of Adverse Reactions including allergic contact dermatitisTimepoint: 4 weeks

Secondary Outcome Measures

Name	Time	Method
1. Dressing Adherence Score <br/ ><br>2. Pain during dressing changes <br/ ><br>3. Any systemic effects after treatment <br/ ><br>Incidence of BlisteringTimepoint: 10 days <br/ ><br>2 weeks <br/ ><br> <br/ ><br>6 days