A trial evaluating outcomes of immediate implant-based breast reconstruction using an acellular dermal matrix (ADM) (POBRAD trial)

ISRCTN	ISRCTN67956295
DOI	https://doi.org/10.1186/ISRCTN67956295
Protocol serial number	Pobrad trial ref.11/LO/0336. 15th August2011, version 2.1
Sponsor	King's College of London (UK)
Funder	TEI Biosciences Inc. Boston, MA (USA) - Educational grant

Submission date: 13/02/2013
Registration date: 04/03/2013
Last edited: 30/01/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-using-sheet-of-tissue-improve-breast-reconstruction-surgery-pobrad?

Contact information

Mr Michael Douek
Scientific

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

Study information

Primary study design	Observational
Study design	Prospective open label non-randomised longitudinal observational study
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
Scientific title	Prospective, open-label trial evaluating Outcomes of immediate implant-based Breast Reconstruction using an Acellular Dermal matrix (ADM) (POBRAD trial)
Study acronym	POBRAD
Study objectives	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 ADMs (SurgiMend PRS) as an adjunct in implant breast reconstruction.
Ethics approval(s)	London-Bentham Research Ethics Committee London East, REC approval: 05/05/2011, ref: 11/LO/0336
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Mastectomy-site complication rate 2. Implant-related complication rate 3. Return to theatre rate Measured 1, 3 and 12 months post surgery
Key secondary outcome measure(s)	1. Cosmetic outcome 2. Patient reported outcome 3. Cost-benefit analysis
Completion date	31/07/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	40
Key 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
Key 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
Date of first enrolment	20/07/2011
Date of final enrolment	31/07/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Guy's and St Thomas' Hospitals

London
SE1 9RT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2013	30/01/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

30/01/2020: Publication reference added.
23/06/2016: No publications found, verifying study status with principal investigator