Clinical Trial To Study The Anti-scarring Effect Of Cicatricell

Not Applicable

Completed

• Conditions: Surgical Incisions
• Interventions: Other: Cicatricell Cream

• Registration Number: NCT03020420
• Lead Sponsor: University of Toledo Health Science Campus

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-09-16
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-13
• Primary Completion: 2018-12
• Study Completion: 2020-12
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment arm	Cicatricell Cream	receive cicatricell cream

Primary Outcome Measures

Name	Time	Method
Modified Vancouver Scar Scale	8 weeks to 6 months	a scale of visual assessment of a scar
Improved wound appearance	8 weeks to 6 months	improved wound appearance by surface area measurement
improved wound appearance	8 weeks to 6 months	wound bulge measured with caliper
Manchester Scar Scale	8 weeks to 6 months	A new quantitative scale for clinical scar assessment

Trial Locations

Locations (1)

UTMC; 🇺🇸 Toledo, Ohio, United States