Celotres for Improvement in Wound Healing and Resulting Scar Consequences Following Suturing of a Wound
PMCS EURO HEAL
A Post Market Clinical Study Evaluating the Safety, Device Performance and Possible Emergent Risks of Celotres in the Improvement of Wound Healing and the Resulting Scar Consequences Following Suturing of a Wound
1 other identifier
interventional
60
2 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2012
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 3, 2012
CompletedFirst Posted
Study publicly available on registry
October 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMay 28, 2014
August 1, 2013
1.7 years
October 3, 2012
May 24, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Safety
Safety as defined by the incidence of device related adverse events.
Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12
Secondary Outcomes (2)
Effectiveness
Assessed at Months 1, 3, 6, 9 and 12
Device Performance Evaluation
Assessed at Day 1
Study Arms (2)
Celotres
ACTIVE COMPARATORScar halves randomized to treatment with device, opposite side treated per standard of care.
Standard surgical wound closure
ACTIVE COMPARATORScar halves randomized to treatment with device, opposite side treated per standard of care.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients electing to undergo a surgical procedure;
- Patients able and willing to give written informed consent
You may not qualify if:
- Patients with a known or potential risk of allergy or sensitivity to products or substances containing porcine gelatin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Halscion, Inc.lead
Study Sites (9)
Angelius Szpital Proviat
Katowice, Poland
Oddzial Leczenia Oparzen Chirugil Plastysznej
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Venkat Ramakrishnan, MD
Brentwood Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2012
First Posted
October 15, 2012
Study Start
September 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
May 28, 2014
Record last verified: 2013-08