Celotres for Improvement in Wound Healing and Resulting Scar Consequences Following Suturing of a Wound
- Conditions
- Scar
- Registration Number
- NCT01706848
- Lead Sponsor
- Halscion, Inc.
- 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 improve wound healing and the resulting scar consequences following suturing of a wound.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Patients electing to undergo a surgical procedure;
- Patients able and willing to give written informed consent
- Patients with a known or potential risk of allergy or sensitivity to products or substances containing porcine gelatin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12 Safety as defined by the incidence of device related adverse events.
- Secondary Outcome Measures
Name Time Method Effectiveness Assessed at Months 1, 3, 6, 9 and 12 Patient and Observer Scar Assessment Scale (POSAS)
Device Performance Evaluation Assessed at Day 1 Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator
Trial Locations
- Locations (9)
Angelius Szpital Proviat
🇵🇱Katowice, Poland
Oddzial Leczenia Oparzen Chirugil Plastysznej
🇵🇱Krakow, Poland
Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej
🇵🇱Warsaw, Poland
The Westbourne Center
🇬🇧Birmingham, United Kingdom
Brentwood Hospital
🇬🇧Brentwood, United Kingdom
Plastic Surgery W1 Ltd, Suite 1
🇬🇧London, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle Upon Tyne, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, United Kingdom
Morriston Hospital
🇬🇧Swansea, United Kingdom
Angelius Szpital Proviat🇵🇱Katowice, Poland