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 (EURO KLEAR)

Halscion

Status: Completed

Conditions: Earlobe Keloids

Treatments: Device: Celotres

Study type: Interventional

Funder types: Industry

Identifiers

NCT01706861

HAL-302

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Celotres

Other group

Description:

Celotres following surgical removal of earlobe keloid.

Treatment:

Device: Celotres