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This study aims to determine if a silicon-based gel and a silicon-based aerosol are effective in the treatment of postoperative scars.
Improve the final aspect of scars, have been a challenge for medicine. Silicon based products have been used in various ways to prevent hypertrophic scars and keloids since 1980. A great percentage of studies shows that silicon-based products improves the aspect of scars in different pathologies. The main objective of this trial is to evaluate the efficacy, using the Vancouver scale, of two silicon-based products (Kelofin gel and Kelofin aerosol) after 180 days.
300 participants that meet all the inclusion criteria and are not classified in any of the exclusion criteria will be randomly allocated to one of thre treatment groups( Kelofin Gel, Kelofin Aerosol and no treatment) of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kelofin Aerosol | Experimental | Silicon-based Aerosol that will be applied over the postoperative scar two times a day |
|
| Kelofin Gel | Experimental | Silicon-based Gel that will be applied over the postoperative scar two times a day |
|
| Control | No Intervention | This group will not receive any intervention as a control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silicon-based aerosol | Other | Apply twice a day over the postoperative scar |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of scars clinical improvement | The scars will be evaluated by the Vancouver scale since the baseline visit until 180 days after the end of the treatment. | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of scars color improvement | The scars will be evaluated by the equipment Mexameter (Courage+Khazaka®) since the baseline visit until 180 days after the end of the treatment. | 180 days |
| Evaluation of scars measurement improvement |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Silicon-based gel | Other | Apply twice a day over the postoperative scar |
|
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The scars will be evaluated by the equipment Optical 3D Skin Measuring Device PRIMOS Compact 5.075, since the baseline visit until 180 days after the end of the treatment.
| 180 days |
| Participants satisfaction regarding the treatment | Assess the satisfaction of participants regarding the treatment on each visit using a questionnaire on improving the healing process | 180 days |
| Adverse events occurrence | Adverse events will be evaluated since the baseline visit until 180 days after the end of the treatment. | 180 days |