Back to resultsA 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)
Primary Purpose
Earlobe Keloids
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Celotres
Sponsored by
About this trial
This is an interventional treatment trial for Earlobe Keloids
Eligibility Criteria
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.
Sites / Locations
- University of the West Indies
- Angelius Szpital Proviat
- Oddzial Leczenia Oparzen Chirugil Plastysznej
- Kosmetyczno-Lekarska Spółdzielnia Pracy "IZIS"
- Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej
- The Westbourne Centre
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Celotres
Arm Description
Celotres following surgical removal of earlobe keloid.
Outcomes
Primary Outcome Measures
The incidence of device related adverse events
Device safety is defined as the incidence of device related adverse events.
Recurrence of keloid post scar excision
Proportion of subjects with recurrence of keloid scar post excision defined as the presence of scar tissue volume >0.3cc
Secondary Outcome Measures
Patient and Observer Scar Assessment Scale (POSAS)
Subject Dermatology Life Quality Index (DLQI)
Device Performance Evaluation
Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01706861
Brief Title
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
Acronym
EURO KLEAR
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Halscion, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Earlobe Keloids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Celotres
Arm Type
Other
Arm Description
Celotres following surgical removal of earlobe keloid.
Intervention Type
Device
Intervention Name(s)
Celotres
Intervention Description
Celotres following surgical removal of earlobe keloid.
Primary Outcome Measure Information:
Title
The incidence of device related adverse events
Description
Device safety is defined as the incidence of device related adverse events.
Time Frame
Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12
Title
Recurrence of keloid post scar excision
Description
Proportion of subjects with recurrence of keloid scar post excision defined as the presence of scar tissue volume >0.3cc
Time Frame
Assessed at 1, 3, 6, 9 and 12 months
Secondary Outcome Measure Information:
Title
Patient and Observer Scar Assessment Scale (POSAS)
Time Frame
Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12
Title
Subject Dermatology Life Quality Index (DLQI)
Time Frame
Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12
Title
Device Performance Evaluation
Description
Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator.
Time Frame
Assessed at Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Bella, MD
Organizational Affiliation
The Westbourne Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of the West Indies
City
Nassau
Country
Bahamas
Facility Name
Angelius Szpital Proviat
City
Katowice
Country
Poland
Facility Name
Oddzial Leczenia Oparzen Chirugil Plastysznej
City
Krakow
Country
Poland
Facility Name
Kosmetyczno-Lekarska Spółdzielnia Pracy "IZIS"
City
Warsaw
Country
Poland
Facility Name
Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej
City
Warsaw
Country
Poland
Facility Name
The Westbourne Centre
City
Edgbaston
State/Province
Birmingham
ZIP/Postal Code
B15 3SJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
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
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