ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02557906
Recruitment Status : Active, not recruiting
First Posted : September 23, 2015
Last Update Posted : March 13, 2018
Sponsor:
Collaborators:
Guy's and St Thomas' NHS Foundation Trust
Integra LifeSciences Corporation
Information provided by (Responsible Party):
King's College London

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.


Condition or disease Intervention/treatment Phase
Breast Neoplasms Breast Diseases Procedure: Breast reconstruction - implant and an ADM (SurgiMend) Procedure: Breast reconstruction- autologous tissue Procedure: Breast reconstruction- implant + dermal sling/LD flap Not Applicable

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  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2014
Actual Primary Completion Date : January 2016
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: 30 days ]
    Adverse events defined as implant loss, infection, haematoma, seroma, skin necrosis in all cohorts

  2. Number of patients with adverse events [ Time Frame: 3 months ]
    Adverse events defined as implant loss, infection, haematoma, seroma, skin necrosis in all cohorts

  3. Number of patients with adverse events [ Time Frame: 12 months ]
    Adverse events defined as implant loss, infection, haematoma, seroma, skin necrosis in all cohorts


Secondary Outcome Measures :
  1. Aesthetic outcome measured by Photographic assessment [ Time Frame: 12 months ]
    Photographic assessment

  2. BREAST-Q questionnaire score [ Time Frame: 30 days ]
    Patient-reported outcome measures using the BREASTQ questionnaire

  3. BREAST-Q questionnaire score [ Time Frame: 12 months ]
    Patient-reported outcome measures using the BREASTQ questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557906


Locations
United Kingdom
Royal Hampshire County Hospital
Winchester, Hampshire, United Kingdom
Frimley Park Hospitals NHS Foundation Trust
Frimley, United Kingdom
Leeds Teaching Hospitals
Leeds, United Kingdom
Department of Research Oncology, King's College London
London, United Kingdom, SE1 9RT
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
Sponsors and Collaborators
King's College London
Guy's and St Thomas' NHS Foundation Trust
Integra LifeSciences Corporation
Investigators
Principal Investigator: Michael Douek, MD FRCS King's College London

Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02557906     History of Changes
Other Study ID Numbers: 153962
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Keywords provided by King's College London:
Acellular dermal matrix
ADM
SurgiMend
Breast reconstruction
Immediate breast reconstruction
Autologous reconstruction
Biological mesh

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Neoplasms
Skin Diseases