NCT03020420

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2015

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 5, 2024

Status Verified

June 1, 2024

Enrollment Period

3.8 years

First QC Date

September 16, 2015

Last Update Submit

June 4, 2024

Conditions

Surgical Incisions

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

treatment arm

EXPERIMENTAL

receive cicatricell cream

Other: Cicatricell Cream

control arm

NO INTERVENTION

to treatment

Interventions

Cicatricell CreamOTHER

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

treatment arm

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Known skin allergies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UTMC

Toledo, Ohio, 43614, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2015

First Posted

January 13, 2017

Study Start

March 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2020

Last Updated

June 5, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)