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ISRCTN
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ISRCTN67956295
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DOI
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10.1186/ISRCTN67956295
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A trial evaluating outcomes of immediate implant-based breast reconstruction using an acellular dermal matrix (ADM) (POBRAD trial)
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Scientific title
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Prospective, open-label trial evaluating Outcomes of immediate implant-based Breast Reconstruction using an Acellular Dermal matrix (ADM) (POBRAD trial)
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Acronym
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POBRAD
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Serial number at source
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Pobrad trial ref.11/LO/0336. 15th August2011, version 2.1
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Study hypothesis
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To date there have been a number of retrospective cohorts and case series reporting on outcomes following breast reconstruction using the porcine derived, non-crossed- linked surgical acellular dermal matrix Strattice (LifeCell , Branchburg, NJ) .
An alternative ADM is SurgiMend PRS, (TEI Bioscience Inc. Boston, MA), which is derived from foetal, bovine dermis enriched in type III collagen from which all cellular components have been removed, leaving a structurally intact and biochemically inert extracellular matrix made of elastin, collagen and glycoprotein components.matrix. It is believed to act as a scaffold allowing in-growth and regeneration of tissue following implantation and adding structural support and additional soft tissue cover.
The product is CE marked with an established safety record and indicated as an adjunct in a number of surgical procedures including breast reconstruction. As yet there is no prospective data on ADM use in breast reconstruction to validate clinical efficacy, complication rates and cost-benefit. This study is intended to provide robust, prospective clinically validated outcomes for the use of ADM’s (SurgiMend PRS) as an adjunct in implant breast reconstruction.
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Lay summary
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http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-using-sheet-of-tissue-improve-breast-reconstruction-surgery-pobrad?
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Ethics approval
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London-Bentham Research Ethics Committee London East, REC approval: 05/05/2011, REC reference: 11/LO/0336
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Study design
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Prospective open label non-randomised longitudinal observational study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Breast Cancer
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Participants - inclusion criteria
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1. Any person older than 18 years of age meeting the inclusion criteria are eligible to the study
2. All post-mastectomy patients undergoing immediate implant-based, breast reconstruction requiring lower pole cover
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Participants - exclusion criteria
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1. Significant co-morbidities
2. Body mass index (BMI) >40
3. Locally advanced and/ or inflammatory breast cancer
4. Patients unable to provide informed consent to participate in trial
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Anticipated start date
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20/07/2011
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Anticipated end date
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31/07/2012
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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40
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Interventions
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The POBRAD study aims to prospectively evaluate the complication rate, clinical and cosmetic outcome together with the cost-benefit analysis of the use of an acellular dermal matrix (ADM) for immediate implant based breast reconstruction in a population of newly diagnosed breast cancer patients.
Patients will be assessed for mastectomy-site complication rate, implant related complication rate and return to the theatre rate at post-operative, 1, 3 and 12 months post surgery.
Details of secondary sponsor:
Guy's and St. Thomas' NHS Foundation Trust
3rd Floor Conybeare House
Great Maze Pond
London, SE1 9RT, UK
Tel: 02071885736
Fax: 02071885434
Email:karen.ignatian@gstt.nhs.uk
Website: http://www.guysandstthomas.nhs.uk
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Primary outcome measure(s)
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1. Mastectomy-site complication rate
2. Implant-related complication rate
3. Return to theatre rate
Measured 1, 3 and 12 months post surgery
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Secondary outcome measure(s)
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1. Cosmetic outcome
2. Patient reported outcome
3. Cost-benefit analysis
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Sources of funding
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TEI Biosciences Inc. Boston, MA (USA) - Educational grant
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Trial website
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Publications
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Contact name
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Mr
Michael
Douek
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Address
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Guy's and St Thomas' Hospitals
3rd Floor Bermondsey Wing
Great Maze Pond
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City/town
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London
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Zip/Postcode
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SE1 9RT
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Country
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United Kingdom
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Sponsor
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King's College of London (UK)
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Address
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Room 1.8 Hodgkin Building
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City/town
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London
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Zip/Postcode
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SE1 1UL
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Country
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United Kingdom
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Tel
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+44 (0)20 7188 5736
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Fax
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+44 (0)20 7188 5434
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Email
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michael.douek@kcl.ac.uk
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Sponsor website:
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http://www.kcl.ac.uk
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Date applied
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13/02/2013
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Last edited
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04/03/2013
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Date ISRCTN assigned
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04/03/2013
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