Clinical Trial To Study The Anti-scarring Effect Of Cicatricell

Surgical Incisions Clinical Trial

— Cicatricell  

Official title:

Clinical Trial To Study The Anti-scarring Effect Of Cicatricell

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03020420
• Other study ID #: Cicatricell
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: December 2020

Study information

• Verified date: June 2024
• Source: University of Toledo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Surgical Incisions
• Surgical Wound

Intervention

Other:
• Cicatricell Cream
Cream to be applied 2 times a day for 8weeks to 6 months

Locations

Country	Name	City	State
United States	UTMC	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Toledo Health Science Campus

Country where clinical trial is conducted

United States, 

Outcome

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