ScarPMCS EURO HEALNCT01706848
Celotres for Improvement in Wound Healing and Resulting Scar Consequences Following Suturing of a Wound
A study testing Celotres in people with Scar, run by Halscion, Inc. at 9 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scar
- What is being tested?
- Celotres
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Sep 2012to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients electing to undergo a surgical procedure;
- Patients able and willing to give written informed consent
Who cannot join
- Patients with a known or potential risk of allergy or sensitivity to products or substances containing porcine gelatin
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United Kingdom6 sites
The Westbourne Center
Birmingham, B15 3SJ
Brentwood Hospital
Brentwood, CM15 8EH
Plastic Surgery W1 Ltd, Suite 1
London, W1G9LG
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
Norfolk and Norwich University Hospital
Norwich, NR4 7UY
Morriston Hospital
Swansea, SA6 6NL
Poland3 sites
Angelius Szpital Proviat
Katowice
Oddzial Leczenia Oparzen Chirugil Plastysznej
Krakow
Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej
Warsaw
About this study
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
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.
- Conditions
- Scar
- Being tested
- Celotres, Surgical Closure by Standard of Care
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelotresOther
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.
Surgical Closure by Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Celotres | Active comparator | Scar halves randomized to treatment with device, opposite side treated per standard of care. Receives: Other: Celotres |
| Standard surgical wound closure | Active comparator | Scar halves randomized to treatment with device, opposite side treated per standard of care. Receives: Other: Surgical Closure by Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety as defined by the incidence of device related adverse events.
Measured: Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12
Secondary outcomes (2)
Effectiveness
Patient and Observer Scar Assessment Scale (POSAS)
Measured: Assessed at Months 1, 3, 6, 9 and 12
Device Performance Evaluation
Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator
Measured: Assessed at Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halscion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Venkat Ramakrishnan, MD, Principal investigator, Brentwood Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706848
- Sponsor's protocol ID
- HAL-0297
- Acronym
- PMCS EURO HEAL
- Status last verified
- Aug 2013
- First submitted
- 3 Oct 2012
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01706848
- Acronym / sponsor ID
- PMCS EURO HEAL / HAL-0297
- Conditions
- Scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Halscion, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celotres | Active comparator | Other: CelotresScar halves randomized to treatment with device, opposite side treated per standard of care. |
| Standard surgical wound closure | Active comparator | Other: Surgical Closure by Standard of CareScar halves randomized to treatment with device, opposite side treated per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients electing to undergo a surgical procedure;
- Patients able and willing to give written informed consent
Key exclusion criteria (1 listed)
- Patients with a known or potential risk of allergy or sensitivity to products or substances containing porcine gelatin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelotresSurgical 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 | Celotres |
| Surgical Closure by Standard of CareSurgical 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 | Standard surgical wound closure |
Primary outcome
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.
2 secondary outcomes
Effectiveness
Time frame: Assessed at Months 1, 3, 6, 9 and 12
Device Performance Evaluation
Time frame: Assessed at Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Venkat Ramakrishnan, MD principal investigator
Brentwood Hospital
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celotres in people with Scar, run by Halscion, Inc. at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2014.