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

NCT ID: NCT01706861

Last Updated: 2014-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Earlobe Keloids

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Celotres

Celotres following surgical removal of earlobe keloid.

Group Type OTHER

Celotres

Intervention Type DEVICE

Celotres following surgical removal of earlobe keloid.

Interventions

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Celotres

Celotres following surgical removal of earlobe keloid.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Halscion, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sam Bella, MD

Role: PRINCIPAL_INVESTIGATOR

The Westbourne Centre

Locations

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Angelius Szpital Proviat

Katowice, , Poland

Site Status

Oddzial Leczenia Oparzen Chirugil Plastysznej

Krakow, , Poland

Site Status

Kosmetyczno-Lekarska Spółdzielnia Pracy "IZIS"

Warsaw, , Poland

Site Status

Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej

Warsaw, , Poland

Site Status

University of the West Indies

Nassau, , The Bahamas

Site Status

The Westbourne Centre

Edgbaston, Birmingham, United Kingdom

Site Status

Countries

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Poland The Bahamas United Kingdom

Other Identifiers

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HAL-302

Identifier Type: -

Identifier Source: org_study_id

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