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

Not Applicable

Completed

• Conditions: Scar
• Interventions: Other: Celotres; Other: Surgical Closure by Standard of Care

• Registration Number: NCT01706848
• Lead Sponsor: Halscion, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2012-10-12
• Study First Posted: 2012-10-15
• Status Verified: 2013-08
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-24
• Last Update Posted: 2014-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Celotres	Celotres	Scar halves randomized to treatment with device, opposite side treated per standard of care.
Standard surgical wound closure	Surgical Closure by Standard of Care	Scar halves randomized to treatment with device, opposite side treated per standard of care.

Primary Outcome Measures

Name	Time	Method
Safety	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

Name	Time	Method
Effectiveness	Assessed at Months 1, 3, 6, 9 and 12	Patient and Observer Scar Assessment Scale (POSAS)
Device Performance Evaluation	Assessed at Day 1	Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator

Trial Locations

Locations (9)

Angelius Szpital Proviat; 🇵🇱 Katowice, Poland

Brentwood Hospital; 🇬🇧 Brentwood, United Kingdom

Plastic Surgery W1 Ltd, Suite 1; 🇬🇧 London, United Kingdom

Morriston Hospital; 🇬🇧 Swansea, United Kingdom

Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej; 🇵🇱 Warsaw, Poland

Oddzial Leczenia Oparzen Chirugil Plastysznej; 🇵🇱 Krakow, Poland

Norfolk and Norwich University Hospital; 🇬🇧 Norwich, United Kingdom

The Westbourne Center; 🇬🇧 Birmingham, United Kingdom

Royal Victoria Infirmary; 🇬🇧 Newcastle Upon Tyne, United Kingdom