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

May 24, 2014 updated by: Halscion, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness
Time Frame: Assessed at Months 1, 3, 6, 9 and 12
Patient and Observer Scar Assessment Scale (POSAS)
Assessed at Months 1, 3, 6, 9 and 12
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
Assessed at Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Halscion, Inc.

Investigators

  • Principal Investigator: Venkat Ramakrishnan, MD, Brentwood Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

October 12, 2012

First Posted (Estimate)

October 15, 2012

Study Record Updates

Last Update Posted (Estimate)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 24, 2014

Last Verified

August 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • HAL-0297

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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