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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Earlobe Keloids
- Sponsor
- Halscion, Inc.
- Enrollment
- 51
- Locations
- 6
- Primary Endpoint
- The incidence of device related adverse events
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
The incidence of device related adverse events
Time Frame: 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
Time Frame: 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 Outcomes
- 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)