Condition category
Cancer
Date applied
13/02/2013
Date assigned
04/03/2013
Last edited
23/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mr Michael Douek

ORCID ID

Contact details

Guy's and St Thomas' Hospitals
3rd Floor Bermondsey Wing
Great Maze Pond
London
SE1 9RT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Pobrad trial ref.11/LO/0336. 15th August2011, version 2.1

Study information

Scientific title

Prospective, open-label trial evaluating Outcomes of immediate implant-based Breast Reconstruction using an Acellular Dermal matrix (ADM) (POBRAD trial)

Acronym

POBRAD

Study hypothesis

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.

Ethics approval

London-Bentham Research Ethics Committee London East, REC approval: 05/05/2011, ref: 11/LO/0336

Study design

Prospective open label non-randomised longitudinal observational study

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breast Cancer

Intervention

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

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Mastectomy-site complication rate
2. Implant-related complication rate
3. Return to theatre rate

Measured 1, 3 and 12 months post surgery

Secondary outcome measures

1. Cosmetic outcome
2. Patient reported outcome
3. Cost-benefit analysis

Overall trial start date

20/07/2011

Overall trial end date

31/07/2012

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

40

Participant exclusion criteria

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

Recruitment start date

20/07/2011

Recruitment end date

31/07/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Guy's and St Thomas' Hospitals
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

King's College of London (UK)

Sponsor details

Room 1.8 Hodgkin Building
London
SE1 1UL
United Kingdom
+44 (0)20 7188 5736
michael.douek@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk

Funders

Funder type

Industry

Funder name

TEI Biosciences Inc. Boston, MA (USA) - Educational grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

23/06/2016: No publications found, verifying study status with principal investigator