None listed
Conditions
Interventions
Intervention1: Aloe Wound cream: 1. Aloe arborescens Miller extract- 5%
2.Tea tree essential oil 2%
3. Lavender essential oil- 0.3%
4. Rose hydrosol- 10.2%
5.Dimethicone- 5%
6.Cyclomethicone- 5%
Sponsors
University of Pretoria
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects aged 18 to 50 years with acute wounds (occurring within the last 24 hours). 2. Subjects with superficial and partial thickness skin wounds up to 1 cm depth and 5 cm length. 3. Subjects ready to receive a tetanus toxoid (TT) injection before the application of the study drug at the discretion of the principal investigator (PI). 4. Subjects who agree to have their wound photographed during the trial. 5. Subjects willing to attend all required study visits.
Exclusion criteria
Exclusion criteria: 1. Subjects with infected wounds. 2. Individuals with visceral, bony, or spinal injuries. 3. Individuals with electrical, chemical, or burn injuries. 4. Subjects suffering from systemic diseases such as Diabetes mellitus, tuberculosis, malignant wounds, arterial or varicose ulcers, pressure ulcers, HbsAg positivity, HIV I & II positivity, or other conditions deemed by the investigator to potentially interfere with or delay the wound healing process. 5. Subjects with non-healing wounds/ulcers or infectious diseases. 6. Subject on any investigational drug(s) or therapeutic device(s) within 28 days preceding randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of wound healing over the study period using Bates- Jensen Wound Assessment Tool 2. Assessment of the reduction in clinical symptoms of wound 3. Reduction of pain from baseline to end of the study 4. Assessment of time (number of days) required to achieve complete wound closure verified through photo documentationTimepoint: Day 1, Day 7, Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of skin tolerability throughout the study 2. Incidence of secondary infections during the study period 3. Change in vital signs from baseline to end of the study 4. Change in hematological (CBC), renal function, liver function and urinalysis parameters from baseline to end of the study 5. Incidence of adverse events and serious adverse events during the study period 6. Assessment of patient satisfaction using self-reported questionnaireTimepoint: Day 1, Day 7, Day 14 | — |
Countries
India
Contacts
Public ContactMeena Dalal
TrialGuna Private Limited
Outcome results
None listed