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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01706848
First Posted: October 15, 2012
Last Update Posted: May 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Halscion, Inc.
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    Patient and Observer Scar Assessment Scale (POSAS)

  • Device Performance Evaluation [ Time Frame: Assessed at Day 1 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Halscion, Inc.
ClinicalTrials.gov Identifier: NCT01706848     History of Changes
Other Study ID Numbers: HAL-0297
First Submitted: October 3, 2012
First Posted: October 15, 2012
Last Update Posted: May 28, 2014
Last Verified: August 2013