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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01706861

Acronym

EURO KLEAR

Enrollment

Registered

2012-10-15

Start date

2012-09-30

Completion date

2014-05-31

Last updated

2014-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Earlobe Keloids

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.

Interventions

DEVICECelotres

Celotres following surgical removal of earlobe keloid.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Poland, The Bahamas, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026