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

Halscion, Inc.51 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Earlobe Keloids

Interventions

CelotresDEVICE

Celotres following surgical removal of earlobe keloid.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (6)

Angelius Szpital Proviat

Katowice, Poland

Oddzial Leczenia Oparzen Chirugil Plastysznej

Krakow, Poland

Kosmetyczno-Lekarska Spółdzielnia Pracy "IZIS"

Warsaw, Poland

Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej

Warsaw, Poland

Outcomes

Primary Outcomes

The incidence of device related adverse events

Device safety is defined as the incidence of device related adverse events.

Time frame: 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

Time frame: Assessed at 1, 3, 6, 9 and 12 months

Secondary Outcomes

Patient and Observer Scar Assessment Scale (POSAS)

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

Subject Dermatology Life Quality Index (DLQI)

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

Device Performance Evaluation

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

Time frame: Assessed at Day 1

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.