Celotres for Improvement in Wound Healing and Resulting Scar Consequences Following Suturing of a Wound (PMCS EURO HEAL)
This study is currently recruiting participants.
Verified October 2012 by Halscion, Inc.
Sponsor:
Halscion, Inc.
Information provided by (Responsible Party):
Halscion, Inc.
ClinicalTrials.gov Identifier:
NCT01706848
First received: October 3, 2012
Last updated: October 17, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Scar |
Other: Celotres Other: Surgical Closure by Standard of Care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Halscion, Inc.:
Primary Outcome Measures:
- Safety [ Time Frame: Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12 ] [ Designated as safety issue: Yes ]Safety as defined by the incidence of device related adverse events.
Secondary Outcome Measures:
- Effectiveness [ Time Frame: Assessed at Months 1, 3, 6, 9 and 12 ] [ Designated as safety issue: No ]Patient and Observer Scar Assessment Scale (POSAS)
- Device Performance Evaluation [ Time Frame: Assessed at Day 1 ] [ Designated as safety issue: No ]Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Celotres
Scar halves randomized to treatment with device, opposite side treated per standard of care.
|
Other: Celotres
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.
|
|
Active Comparator: Standard surgical wound closure
Scar halves randomized to treatment with device, opposite side treated per standard of care.
|
Other: Surgical Closure by 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Patients electing to undergo a surgical 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706848
Contacts
| Contact: Andrew Green | 6785345950 | dgreen@halscion.net |
Locations
| Poland | |
| Angelius Szpital Proviat | Recruiting |
| Katowice, Poland | |
| Contact: Zbigniew Lucki, MD | |
| Principal Investigator: Zbigniew Lucki, MD | |
| Oddzial Leczenia Oparzen Chirugil Plastysznej | Recruiting |
| Krakow, Poland | |
| Contact: Kazimierz Cieslik, MD | |
| Principal Investigator: Kazimierz Cieszlik, MD | |
| Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej | Recruiting |
| Warsaw, Poland | |
| Contact: Wojciech Witkowski, MD | |
| Principal Investigator: Wojciech Witkowski, MD | |
| United Kingdom | |
| The Westbourne Center | Recruiting |
| Birmingham, United Kingdom, B15 3SJ | |
| Contact: Fazel Fatah, MD | |
| Principal Investigator: Fazel Fatah, MD | |
| Brentwood Hospital | Not yet recruiting |
| Brentwood, United Kingdom, CM15 8EH | |
| Contact: Venkat Ramakrishnan, MD | |
| Contact: Maria Guilfoyle | |
| Principal Investigator: Venkat Ramakrishnan, MD | |
| Plastic Surgery W1 Ltd, Suite 1 | Not yet recruiting |
| London, United Kingdom, W1G9LG | |
| Contact: David Ross, MD | |
| Principal Investigator: David Ross, MD | |
| Royal Victoria Infirmary | Not yet recruiting |
| Newcastle Upon Tyne, United Kingdom, NE1 4LP | |
| Contact: Nick Collis, MD | |
| Principal Investigator: Nick Collis, MD | |
| Norfolk and Norwich University Hospital | Not yet recruiting |
| Norwich, United Kingdom, NR4 7UY | |
| Contact: Elaine Sassoon, MD | |
| Principal Investigator: Elaine Sassoon, MD | |
| Morriston Hospital | Not yet recruiting |
| Swansea, United Kingdom, SA6 6NL | |
| Contact: Richard Karoo, MD | |
| Principal Investigator: Richard Karoo, MD | |
Sponsors and Collaborators
Halscion, Inc.
Investigators
| Principal Investigator: | Venkat Ramakrishnan, MD | Brentwood Hospital |
More Information
No publications provided
| Responsible Party: | Halscion, Inc. |
| ClinicalTrials.gov Identifier: | NCT01706848 History of Changes |
| Other Study ID Numbers: | HAL-0297 |
| Study First Received: | October 3, 2012 |
| Last Updated: | October 17, 2012 |
| Health Authority: | UK: Health Research Authority Poland: Ethic Committee |
Additional relevant MeSH terms:
|
Cicatrix Fibrosis Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013