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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01706848
Other study ID # HAL-0297
Secondary ID
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


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
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