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

NCT ID: NCT01706848

Last Updated: 2014-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-05-31

Brief Summary

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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

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Conditions

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Scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Celotres

Scar halves randomized to treatment with device, opposite side treated per standard of care.

Group Type ACTIVE_COMPARATOR

Celotres

Intervention Type OTHER

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.

Standard surgical wound closure

Scar halves randomized to treatment with device, opposite side treated per standard of care.

Group Type ACTIVE_COMPARATOR

Surgical Closure by Standard of Care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Halscion, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Venkat Ramakrishnan, MD

Role: PRINCIPAL_INVESTIGATOR

Brentwood Hospital

Locations

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Angelius Szpital Proviat

Katowice, , Poland

Site Status

Oddzial Leczenia Oparzen Chirugil Plastysznej

Krakow, , Poland

Site Status

Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej

Warsaw, , Poland

Site Status

The Westbourne Center

Birmingham, , United Kingdom

Site Status

Brentwood Hospital

Brentwood, , United Kingdom

Site Status

Plastic Surgery W1 Ltd, Suite 1

London, , United Kingdom

Site Status

Royal Victoria Infirmary

Newcastle upon Tyne, , United Kingdom

Site Status

Norfolk and Norwich University Hospital

Norwich, , United Kingdom

Site Status

Morriston Hospital

Swansea, , United Kingdom

Site Status

Countries

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Poland United Kingdom

Other Identifiers

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HAL-0297

Identifier Type: -

Identifier Source: org_study_id

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