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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 improve wound healing and the resulting scar consequences following suturing of a wound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celotres | Active Comparator | Scar halves randomized to treatment with device, opposite side treated per standard of care. |
|
| Standard surgical wound closure | Active Comparator | Scar halves randomized to treatment with device, opposite side treated per standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celotres | Other | Surgical procedure will be performed as per the standard of care. Scar halves randomized to treatment with device (Celotres), opposite side treated per standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety as defined by the incidence of device related adverse events. | Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness | Patient and Observer Scar Assessment Scale (POSAS) | Assessed at 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Venkat Ramakrishnan, MD | Brentwood Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angelius Szpital Proviat | Katowice | Poland | ||||
| Oddzial Leczenia Oparzen Chirugil Plastysznej |
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| Surgical Closure by Standard of Care | Other | Surgical procedure will be performed as per the standard of care. Scar halves randomized to treatment with device (Celotres), opposite side treated per standard of care. |
|
| Assessed at Day 1 |
| Krakow |
| Poland |
| Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej | Warsaw | Poland |
| The Westbourne Center | Birmingham | B15 3SJ | United Kingdom |
| Brentwood Hospital | Brentwood | CM15 8EH | United Kingdom |
| Plastic Surgery W1 Ltd, Suite 1 | London | W1G9LG | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Norfolk and Norwich University Hospital | Norwich | NR4 7UY | United Kingdom |
| Morriston Hospital | Swansea | SA6 6NL | United Kingdom |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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