NCT01706861

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
3 countries

6 active sites

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

September 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 15, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 28, 2014

Status Verified

February 1, 2014

Enrollment Period

1.7 years

First QC Date

October 3, 2012

Last Update Submit

May 24, 2014

Conditions

Earlobe Keloids

Outcome Measures

Primary Outcomes (2)

  • The incidence of device related adverse events

    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

    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 Outcomes (3)

  • Patient and Observer Scar Assessment Scale (POSAS)

    Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12

  • Subject Dermatology Life Quality Index (DLQI)

    Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12

  • Device Performance Evaluation

    Assessed at Day 1

Study Arms (1)

Celotres

OTHER

Celotres following surgical removal of earlobe keloid.

Device: Celotres

Interventions

CelotresDEVICE

Celotres following surgical removal of earlobe keloid.

Celotres

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Angelius Szpital Proviat

Katowice, Poland

Location

Oddzial Leczenia Oparzen Chirugil Plastysznej

Krakow, Poland

Location

Kosmetyczno-Lekarska Spółdzielnia Pracy "IZIS"

Warsaw, Poland

Location

Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej

Warsaw, Poland

Location

University of the West Indies

Nassau, The Bahamas

Location

The Westbourne Centre

Edgbaston, Birmingham, B15 3SJ, United Kingdom

Location

Study Officials

  • Sam Bella, MD

    The Westbourne Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2012

First Posted

October 15, 2012

Study Start

September 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 28, 2014

Record last verified: 2014-02

Locations

TH(1)GB(1)PL(4)