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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.
October 3, 2012
October 15, 2012
May 28, 2014
September 2012
May 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01706848 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Celotres for Improvement in Wound Healing and Resulting Scar Consequences Following Suturing of a Wound
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
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Scar
  • 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.
  • 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.
  • Active Comparator: Celotres
    Scar halves randomized to treatment with device, opposite side treated per standard of care.
    Intervention: Other: Celotres
  • Active Comparator: Standard surgical wound closure
    Scar halves randomized to treatment with device, opposite side treated per standard of care.
    Intervention: Other: Surgical Closure by Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2014
May 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Poland,   United Kingdom
 
 
NCT01706848
HAL-0297
No
Not Provided
Not Provided
Halscion, Inc.
Halscion, Inc.
Not Provided
Principal Investigator: Venkat Ramakrishnan, MD Brentwood Hospital
Halscion, Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP