Clinical Trial To Study The Anti-scarring Effect Of Cicatricell (Cicatricell)
Primary Purpose
Surgical Incisions
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cicatricell Cream
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Incisions
Eligibility Criteria
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.
Sites / Locations
- UTMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
treatment arm
control arm
Arm Description
receive cicatricell cream
to treatment
Outcomes
Primary Outcome Measures
Improved wound appearance
improved wound appearance by surface area measurement
improved wound appearance
wound indentation measurement with caliper
improved wound appearance
wound bulge measured with caliper
Modified Vancouver Scar Scale
a scale of visual assessment of a scar
Manchester Scar Scale
A new quantitative scale for clinical scar assessment
Secondary Outcome Measures
Full Information
NCT ID
NCT03020420
First Posted
September 16, 2015
Last Updated
April 7, 2020
Sponsor
University of Toledo Health Science Campus
1. Study Identification
Unique Protocol Identification Number
NCT03020420
Brief Title
Clinical Trial To Study The Anti-scarring Effect Of Cicatricell
Acronym
Cicatricell
Official Title
Clinical Trial To Study The Anti-scarring Effect Of Cicatricell
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Toledo Health Science Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Incisions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment arm
Arm Type
Experimental
Arm Description
receive cicatricell cream
Arm Title
control arm
Arm Type
No Intervention
Arm Description
to treatment
Intervention Type
Other
Intervention Name(s)
Cicatricell Cream
Intervention Description
Cream to be applied 2 times a day for 8weeks to 6 months
Primary Outcome Measure Information:
Title
Improved wound appearance
Description
improved wound appearance by surface area measurement
Time Frame
8 weeks to 6 months
Title
improved wound appearance
Description
wound indentation measurement with caliper
Time Frame
8 weeks to 6 months
Title
improved wound appearance
Description
wound bulge measured with caliper
Time Frame
8 weeks to 6 months
Title
Modified Vancouver Scar Scale
Description
a scale of visual assessment of a scar
Time Frame
8 weeks to 6 months
Title
Manchester Scar Scale
Description
A new quantitative scale for clinical scar assessment
Time Frame
8 weeks to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chris Eisenhauer
Phone
4193836784
Email
christina.eisenhaue@utoledo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Munier Nazzal, MD
Phone
4193835150
Email
munier.nazzal@utoledo.edu
Facility Information:
Facility Name
UTMC
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Eisenhauer
Phone
419-383-6784
Email
christina.eisenhauer@utoledo.edu
First Name & Middle Initial & Last Name & Degree
Munier Nazzal, MD
Phone
419-383-6810
Email
munier.nazzal@utoledo.edu
First Name & Middle Initial & Last Name & Degree
Munier Nazzal, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Trial To Study The Anti-scarring Effect Of Cicatricell
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