Clinical Trial To Study The Anti-scarring Effect Of Cicatricell (Cicatricell)

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

Study Overview

• Status: Completed
• Conditions: Surgical Incisions
• Intervention / Treatment: Other: Cicatricell Cream

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43614
      • UTMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Toledo Health Science Campus

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: September 16, 2015
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (Estimated): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: Cicatricell

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO