Efficacy Study of Two Silicon-based Products to Treat Scars

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparative, Open, Randomized Trial Between Two Silicon-based Products to Treat Postoperative Scars

Conditions
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Scars

Intervention / Treatment
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* Other: Silicon-based aerosol
* Other: Silicon-based gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fitzpatrick skin phototype I, II, III or IV Participant that has a recent surgical scar on remodeling phase (14 ± 7 days after surgery) from the following: breast plastic with inframammary incision (fold beneath the breast) or abdominoplasty, cesarean section, hysterectomy (removal of the uterus), oophorectomy (removal of ovaries), oophoroplasty (removal of nodules, cysts, etc. of the ovaries), salpingectomy (removal of the fallopian tubes), tubal ligation, exploratory laparotomy and ectopic pregnancy (pregnancy outside the uterus) (Pfannenstiel access road - transverse incision , below the navel and approximately one finger above the symphysis pubis). Exclusion Criteria: Skin Pathology in the product application area; Diabetes; Immune impairment; Use of systemic corticosteroids or immunosuppressants; Skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis; Background reaction to silicon-based products; Other illnesses or medications that may interfere directly in the study or endanger the health of the participant.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kelofin Aerosol<br>Silicon-based Aerosol that will be applied over the postoperative scar two times a day | Other: Silicon-based aerosol<br>* Apply twice a day over the postoperative scar<br>* Other names: Kelofin Aerosol;|
| Experimental: Kelofin Gel<br>Silicon-based Gel that will be applied over the postoperative scar two times a day | Other: Silicon-based gel<br>* Apply twice a day over the postoperative scar<br>* Other names: Kelofin Gel;|
| No Intervention: Control<br>This group will not receive any intervention as a control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative scars, Cicatrix, Cicatrization