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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celotres | Other | Celotres following surgical removal of earlobe keloid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celotres | Device | Celotres following surgical removal of earlobe keloid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of device related adverse events | Device safety is defined as the incidence of device related adverse events. | 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 | Assessed at 1, 3, 6, 9 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sam Bella, MD | The Westbourne Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angelius Szpital Proviat | Katowice | Poland | ||||
| Oddzial Leczenia Oparzen Chirugil Plastysznej |
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| Device Performance Evaluation | Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator. | Assessed at Day 1 |
| Krakow |
| Poland |
| Kosmetyczno-Lekarska Spółdzielnia Pracy "IZIS" | Warsaw | Poland |
| Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej | Warsaw | Poland |
| University of the West Indies | Nassau | The Bahamas |
| The Westbourne Centre | Edgbaston | Birmingham | B15 3SJ | United Kingdom |