Clinical Trial To Study The Anti-scarring Effect Of Cicatricell

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2020-12-31

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.

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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.

Conditions

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Surgical Incisions

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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treatment arm

receive cicatricell cream

Group Type EXPERIMENTAL

Cicatricell Cream

Intervention Type OTHER

Cream to be applied 2 times a day for 8weeks to 6 months

control arm

to treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cicatricell Cream

Cream to be applied 2 times a day for 8weeks to 6 months

Intervention Type OTHER

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.