Celotres for Improvement in Wound Healing and Resulting Scar Consequences Following Suturing of a Wound

Scar Clinical Trial

— PMCS EURO HEAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01706848
• Other study ID #: HAL-0297
• Status: Completed
• Phase: N/A
• First received: October 3, 2012
• Last updated: May 24, 2014
• Start date: September 2012
• Est. completion date: May 2014

Study information

• Verified date: August 2013
• Source: Halscion, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: UK: Health Research AuthorityPoland: Ethic Committee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scar

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	Angelius Szpital Proviat	Katowice
Poland	Oddzial Leczenia Oparzen Chirugil Plastysznej	Krakow
Poland	Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej	Warsaw
United Kingdom	The Westbourne Center	Birmingham
United Kingdom	Brentwood Hospital	Brentwood
United Kingdom	Plastic Surgery W1 Ltd, Suite 1	London
United Kingdom	Royal Victoria Infirmary	Newcastle Upon Tyne
United Kingdom	Norfolk and Norwich University Hospital	Norwich
United Kingdom	Morriston Hospital	Swansea

Sponsors (1)

Lead Sponsor	Collaborator
Halscion, Inc.

Countries where clinical trial is conducted

Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Safety as defined by the incidence of device related adverse events.	Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12	Yes
Secondary	Effectiveness	Patient and Observer Scar Assessment Scale (POSAS)	Assessed at Months 1, 3, 6, 9 and 12	No
Secondary	Device Performance Evaluation	Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator	Assessed at Day 1	No