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Completed

NCT Number: NCT03020420

Clinical Trial To Study The Anti-scarring Effect Of Cicatricell

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

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Key information

Conditions

Surgical Incisions Surgical Wound Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UTMC

Toledo, Ohio, 43614, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cicatricell Cream

Other

Cream to be applied 2 times a day for 8weeks to 6 months

Primary outcomes

  1. Improved wound appearance

    Time frame: 8 weeks to 6 months

    improved wound appearance by surface area measurement

  2. improved wound appearance

    Time frame: 8 weeks to 6 months

    wound indentation measurement with caliper

  3. improved wound appearance

    Time frame: 8 weeks to 6 months

    wound bulge measured with caliper

  4. Modified Vancouver Scar Scale

    Time frame: 8 weeks to 6 months

    a scale of visual assessment of a scar

  5. Manchester Scar Scale

    Time frame: 8 weeks to 6 months

    A new quantitative scale for clinical scar assessment

Sponsors and collaborators

Lead sponsor

University of Toledo Health Science Campus

Other

Registry information

Acronym: Cicatricell

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Jan 13, 2017
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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