Clinical Trial To Study The Anti-scarring Effect Of Cicatricell

Study Overview
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Brief Summary
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This study tries to prove that Cicatricell cream significantly reduces scarring with better wound appearance as compared to no treatment.

Detailed Description
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At 1st post operative follow up visit, surgical incision(s) will be assessed for healing, after the sutures/staples/steri-strips are removed. To be included in the study the incision must be 5cm or greater. And bilateral incisions as in bilateral mastectomy can be included. The incisions will be divided into two sections, using an imaginary line between top and bottom, or left and right. One side of the imaginary line will have cicatricell cream applied 2 times a day for a minimum of 8 weeks and a maximum 6months. The other side of the imaginary line will remain untreated. In the case of a bilateral incision, as in bilateral breast mastectomy or AAA incisions in the groins, the cream will be applied to one entire incision and the 2nd incision will be untreated. The incision(s) will be its own control group. At the end of the treatment phase the incision(s) will be assessed again to compare the healing.

Official Title
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Clinical Trial To Study The Anti-scarring Effect Of Cicatricell

Conditions
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Surgical Incisions

Intervention / Treatment
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* Other: Cicatricell Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed IRB approved, written informed consent. Patient from 18 to 60 years of age. Patient who recently underwent a surgery involving linear surgical skin incisions of 5cm or more or patients with two exactly symmetrical separate incisions like bilateral inguinal hernia repair or bilateral mastectomy, CT surgery patients will be included. Exclusion Criteria: Known skin allergies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment arm<br>receive cicatricell cream | Other: Cicatricell Cream<br>* Cream to be applied 2 times a day for 8weeks to 6 months<br>|
| No Intervention: control arm<br>to treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved wound appearance | improved wound appearance by surface area measurement | 8 weeks to 6 months | 
| improved wound appearance | wound indentation measurement with caliper | 8 weeks to 6 months | 
| improved wound appearance | wound bulge measured with caliper | 8 weeks to 6 months | 
| Modified Vancouver Scar Scale | a scale of visual assessment of a scar | 8 weeks to 6 months | 
| Manchester Scar Scale | A new quantitative scale for clinical scar assessment | 8 weeks to 6 months |