Clinical trial NCT02557906: Evaluating Outcomes of Immediate Breast Reconstruction (POBRAD-M)
Official title: Prospective, Multi-centre, Observational Trial Evaluating Outcomes of Immediate Breast Reconstruction Using an Implant and Acellular Dermal Matrix (SurgiMend) or Autologous Tissue
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Breast Diseases
Keywords: Acellular dermal matrix
ADM
SurgiMend
Breast reconstruction
Immediate breast reconstruction
Autologous reconstruction
Biological mesh
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
name: Integra LifeSciences Corporation
First posted: 2015-09-23
Enrollment: 209
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: 30 days
measure: Number of patients with adverse events
timeFrame: 3 months
measure: Number of patients with adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Aesthetic outcome measured by Photographic assessment
timeFrame: 12 months
measure: BREAST-Q questionnaire score
timeFrame: 30 days
measure: BREAST-Q questionnaire score
timeFrame: 12 months
Other outcomes:
Locations:
city: Winchester
country: United Kingdom
facility: Royal Hampshire County Hospital
state: Hampshire
city: Frimley
country: United Kingdom
facility: Frimley Park Hospitals NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals
city: London
country: United Kingdom
facility: Department of Research Oncology, King's College London
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
Study officials:
affiliation: King's College London
name: Michael Douek, MD FRCS
role: PRINCIPAL_INVESTIGATOR
References: