Cicatrix
Conditions
Keywords
Scar, Allium Cepa, post-cesarean
Brief summary
The objectives of this study were to evaluate efficacy and safety of silicone cream containing Allium Cepa extract in post-cesarean surgical scars treatment. Post-cesarean surgical scars were equally seperated into 2 parts (left part and right part). Silicone cream containing Allium Cepa extract or commercial scar gel was ramdomly assigned to apply on left part or right part of the scar. They will be applied 2 times per day (morning and evening) for 3 months. Patient and Observer Scar Assessment Scale (POSAS) , Vancouver scar scale (VSS), melanin index, and erythema index (using cutometer) were used for scar evaluation at 0, 1,2,and 3 months. Moreover, adverse effects were also observed.
Interventions
DEVICEsilicone cream containing Allium Cepa extract
silicone cream containing Allium Cepa extract contains 10% of Allium cepa bulb extract.
DEVICECommercial scar gel
Commercial scar gel is a topical silicone gel. It contains cyclic and polymeric siloxanes and Vitamin C ester.
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-40 years * Have Post-Cesarean Surgical Scars at least 1 month * REEDA scale = 0 score * Able to read and write Thai * Able to follow the research plan * Able to meet all the researchers throughout the period of participation in the project
Exclusion criteria
* Apply other topical application at the post-cesarean surgical scars within 2 weeks before participating in the study and during the study * There is radiation in the area of the post-cesarean surgical scars * Chronic skin diseases such as psoriasis, chronic dermatitis, allergies * Immune deficient or use immunosuppressants within 2 weeks before participating in the study and during the study * Have a history of silicone allergy or onion extract
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient and Observer Scar Assessment Scale | 3 months | The range of score is 1 to 10. Noraml skin will be recorded as scale 1. Higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vancouver scar scale | 3 months | The range of score is 0 to 10. Higher scores mean a worse outcome. |
| Melanin index | 3 months | Melanin index will be evaluated using cutometer. |
| Erythema index | 3 months | Erythema index will be evaluated using cutometer. |
| Adverse effect | 3 months | Adverse effect will be observed in term of erythema, edema, papules, vesicles, and bullae. The range of erythema score is 0 to 3. The range of edema score is 0 to 4. Higher scores mean a worse outcome. Papules, vesicles, and bullae will be recorded as apperance or clear. |
Contacts
Primary ContactPornanong Aramwit, Ph.D
Outcome results
None listed