A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid Lesions Treated Adjunctive to Surgical Excision (EURO KLEAR)

May 24, 2014 updated by: Halscion, Inc.

A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid LEsions Treated Adjunctive to suRgical Excision. PMCS: EURO-KLEAR

The objective of the study is to actively gather additional information on safety, device performance and possible emergent risks following the use of Celotres in a post-market setting when used to reduce the recurrence rate, volume, appearance and/or symptoms associated with keloid scarring in subjects undergoing surgical excision of keloids as compared to the scientific literature.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bahamas
      • Nassau, Bahamas
        • University of the West Indies
  • Poland
      • Katowice, Poland
        • Angelius Szpital Proviat
      • Krakow, Poland
        • Oddzial Leczenia Oparzen Chirugil Plastysznej
      • Warsaw, Poland
        • Kosmetyczno-Lekarska Spółdzielnia Pracy "IZIS"
      • Warsaw, Poland
        • Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej
  • United Kingdom
    • Birmingham
      • Edgbaston, Birmingham, United Kingdom, B15 3SJ
        • The Westbourne Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients electing to undergo keloid excision procedure
  • Patients able and willing to give written informed consent

Exclusion Criteria:

  • Patients with a known or potential risk of allergy or sensitivity to products or substances containing porcine gelatin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Celotres
Celotres following surgical removal of earlobe keloid.
Device: Celotres
Celotres following surgical removal of earlobe keloid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of device related adverse events
Time Frame: Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12
Device safety is defined as the incidence of device related adverse events.
Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12
Recurrence of keloid post scar excision
Time Frame: Assessed at 1, 3, 6, 9 and 12 months
Proportion of subjects with recurrence of keloid scar post excision defined as the presence of scar tissue volume >0.3cc
Assessed at 1, 3, 6, 9 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient and Observer Scar Assessment Scale (POSAS)
Time Frame: Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12
Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12
Subject Dermatology Life Quality Index (DLQI)
Time Frame: Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12
Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12
Device Performance Evaluation
Time Frame: Assessed at Day 1
Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator.
Assessed at Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Halscion, Inc.

Investigators

  • Principal Investigator: Sam Bella, MD, The Westbourne Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

October 12, 2012

First Posted (Estimate)

October 15, 2012

Study Record Updates

Last Update Posted (Estimate)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 24, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAL-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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