Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Celotres for Improvement in Wound Healing and Resulting Scar Consequences Following Suturing of a Wound (PMCS EURO HEAL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Halscion, Inc.
ClinicalTrials.gov Identifier:
NCT01706848
First received: October 3, 2012
Last updated: May 24, 2014
Last verified: August 2013
  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
Study Completion Date: May 2014
Primary Completion Date: May 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706848

Locations
Poland
Angelius Szpital Proviat
Katowice, Poland
Oddzial Leczenia Oparzen Chirugil Plastysznej
Krakow, Poland
Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej
Warsaw, Poland
United Kingdom
The Westbourne Center
Birmingham, United Kingdom, B15 3SJ
Brentwood Hospital
Brentwood, United Kingdom, CM15 8EH
Plastic Surgery W1 Ltd, Suite 1
London, United Kingdom, W1G9LG
Royal Victoria Infirmary
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Norfolk and Norwich University Hospital
Norwich, United Kingdom, NR4 7UY
Morriston Hospital
Swansea, United Kingdom, SA6 6NL
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: May 24, 2014
Health Authority: UK: Health Research Authority
Poland: Ethic Committee

ClinicalTrials.gov processed this record on November 20, 2014