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

Not Applicable

Completed

• Conditions: Earlobe Keloids
• Interventions: Device: Celotres

• Registration Number: NCT01706861
• Lead Sponsor: Halscion, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2012-10-12
• Study First Posted: 2012-10-15
• Status Verified: 2014-02
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-24
• Last Update Posted: 2014-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Celotres	Celotres	Celotres following surgical removal of earlobe keloid.

Primary Outcome Measures

Name	Time	Method
The incidence of device related adverse events	Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12	Device safety is defined as the incidence of device related adverse events.
Recurrence of keloid post scar excision	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

Secondary Outcome Measures

Name	Time	Method
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	Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator.

Trial Locations

Locations (6)

University of the West Indies; 🇧🇸 Nassau, Bahamas

Kosmetyczno-Lekarska Spółdzielnia Pracy "IZIS"; 🇵🇱 Warsaw, Poland

Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej; 🇵🇱 Warsaw, Poland

Oddzial Leczenia Oparzen Chirugil Plastysznej; 🇵🇱 Krakow, Poland

Angelius Szpital Proviat; 🇵🇱 Katowice, Poland

The Westbourne Centre; 🇬🇧 Edgbaston, Birmingham, United Kingdom