Evaluating Outcomes of Immediate Breast Reconstruction (POBRAD-M) (POBRAD-M)

Prospective, Multi-centre, Observational Trial Evaluating Outcomes of Immediate Breast Reconstruction Using an Implant and Acellular Dermal Matrix (SurgiMend) or Autologous Tissue

Some women with breast cancer have their whole breast removed as part of their treatment (mastectomy). Of these women, around 31% have more surgery to create a new breast.There are two main ways to create a new breast(i)using tissue from elsewhere on the body ("autologous" reconstruction )or (ii)using a silicone implant.

In recent years, it has been reported that by using a material called an "acellular dermal matrix" (ADM) the results of breast reconstruction surgery using an implant can be improved. ADMs are materials which originally come from animal or human skin. They act like a sling, supporting the lower part of an implant beneath the skin.

Although ADMs have been approved for used in breast reconstruction and are safe, there is very little high quality evidence to back up their reported benefits, and some studies have suggested their use may in fact increase complications.

The main purpose of this study is to find out what the actual risks and benefits of using an ADM in breast reconstruction surgery are. The investigators will follow the progress of women who have an implant based reconstruction to observe if participants develop problems; what those problems are and how participants feel about the results of their surgery. The investigators also follow the progress of women who undergo autologous reconstruction or alternative reconstructive techniques using an implant for the same reasons.

Study Overview

• Status: Unknown
• Conditions: Breast Neoplasms; Breast Diseases
• Intervention / Treatment: Procedure: Breast reconstruction - implant and an ADM (SurgiMend); Procedure: Breast reconstruction- autologous tissue; Procedure: Breast reconstruction- implant + dermal sling/LD flap

Detailed Description

Despite the widespread adoption of acellular dermal matrices (ADMs) in breast reconstruction, there is limited prospective or high quality evidence on the outcomes of their use. The majority of studies on ADM are poor quality retrospective cohort studies with ill-defined, non-standardised outcome measures and heterogeneous patient populations. Recent systematic reviews have raised concerns of increased infection and seroma rates associated with ADM use which, if correct, may negate their reported advantages. Furthermore there is little high quality evidence to confirm the benefits associated with their use such as improved aesthetic outcomes.

The POBRAD-M is a prospective, multicentre trial which will evaluate the early and late outcomes of immediate breast reconstruction using either an implant and ADM, autologous tissue or an alternative implant-based technique. All participants must have been deemed suitable at the outset for implant based reconstruction with an ADM irrespective of their final procedure choice. All participants will be followed up at 30 days, 3 months and 12 months to record the incidence of complications (to include implant loss, infection, seroma, haematoma and skin necrosis). Additionally Patient Reported Outcomes measures using the BREAST-Q questionnaire will be determined at 30 days and 12 months, and aesthetic outcome will be determined by panel assessment of post-operative photographs at 12 months post-operatively.

• Study Type: Interventional
• Enrollment (Actual): 209
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Frimley, United Kingdom
    • Frimley Park Hospitals NHS Foundation Trust
  • Leeds, United Kingdom
    • Leeds Teaching Hospitals
  • London, United Kingdom, SE1 9RT
    • Department of Research Oncology, King's College London
  • Sheffield, United Kingdom
    • Sheffield Teaching Hospitals NHS Foundation Trust
  • Truro, United Kingdom
    • Royal Cornwall Hospital
  • Hampshire
    • Winchester, Hampshire, United Kingdom
      • Royal Hampshire County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Informed consent given
• Unilateral or bilateral mastectomy (therapeutic, contra lateral or prophylactic)
• Immediate reconstruction;
• Suitable for immediate implant reconstruction with ADM

Exclusion Criteria:

• Patients unable to provide informed consent to participate in trial
• Patients unavailable for follow-up
• Not eligible for immediate breast reconstruction using an ADM

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implant and Surgimend; Breast reconstruction surgery with an implant and an ADM (Surgimend)	Procedure: Breast reconstruction - implant and an ADM (SurgiMend); Skin or nipple sparing mastectomy and immediate breast reconstruction with implants and SurgiMend; Other Names: SurgiMend
Active Comparator: Autologous tissue; Breast reconstruction surgery with autologous tissue	Procedure: Breast reconstruction- autologous tissue; Skin or nipple sparing mastectomy and immediate breast reconstruction with autologous tissue
Active Comparator: Implant + dermal sling/LD flap; Breast reconstruction surgery using a dermal sling or a latissimus dorsi (LD)flap	Procedure: Breast reconstruction- implant + dermal sling/LD flap; Skin or nipple sparing mastectomy and immediate breast reconstruction using an implant and a dermal sling or a latissimus dorsi flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with adverse events	Adverse events defined as implant loss, infection, haematoma, seroma, skin necrosis in all cohorts	30 days
Number of patients with adverse events	Adverse events defined as implant loss, infection, haematoma, seroma, skin necrosis in all cohorts	3 months
Number of patients with adverse events	Adverse events defined as implant loss, infection, haematoma, seroma, skin necrosis in all cohorts	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aesthetic outcome measured by Photographic assessment	Photographic assessment	12 months
BREAST-Q questionnaire score	Patient-reported outcome measures using the BREASTQ questionnaire	30 days
BREAST-Q questionnaire score	Patient-reported outcome measures using the BREASTQ questionnaire	12 months

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Guy's and St Thomas' NHS Foundation Trust; Integra LifeSciences Corporation
• Investigators: Principal Investigator: Michael Douek, MD FRCS, King's College London

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: July 28, 2015
• First Submitted That Met QC Criteria: September 22, 2015
• First Posted (Estimate): September 23, 2015

Study Record Updates

• Last Update Posted (Actual): March 13, 2018
• Last Update Submitted That Met QC Criteria: March 12, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Breast reconstruction; ADM; Acellular dermal matrix; SurgiMend; Immediate breast reconstruction; Autologous reconstruction; Biological mesh
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Neoplasms; Breast Diseases
• Other Study ID Numbers: 153962