Clinical Trial To Study The Anti-scarring Effect Of Cicatricell

University of Toledo Health Science Campus

Status: Completed

Conditions: Surgical Incisions

Treatments: Other: Cicatricell Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT03020420

Cicatricell

Details and patient eligibility

About

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

Full description

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

treatment arm

Experimental group

Description:

receive cicatricell cream

Treatment:

Other: Cicatricell Cream

control arm

No Intervention group

Description:

to treatment