Evaluating Outcomes of Immediate Breast Reconstruction (POBRAD-M)

Breast Neoplasms Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02557906
• Other study ID #: 153962
• Status: Active, not recruiting
• Phase: N/A
• First received: July 28, 2015
• Last updated: March 12, 2018
• Start date: July 2014
• Est. completion date: January 2020

Study information

• Verified date: March 2018
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 209
• Est. completion date: January 2020
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Diseases
• Breast Neoplasms

Intervention

Procedure:
• Breast reconstruction - implant and an ADM (SurgiMend)
Skin or nipple sparing mastectomy and immediate breast reconstruction with implants and SurgiMend
• Breast reconstruction- autologous tissue
Skin or nipple sparing mastectomy and immediate breast reconstruction with autologous tissue
• 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

Locations

Country	Name	City	State
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	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield
United Kingdom	Royal Cornwall Hospital	Truro
United Kingdom	Royal Hampshire County Hospital	Winchester	Hampshire

Sponsors (3)

Lead Sponsor	Collaborator
King's College London	Guy's and St Thomas' NHS Foundation Trust, Integra LifeSciences Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events	Adverse events defined as implant loss, infection, haematoma, seroma, skin necrosis in all cohorts	30 days
Primary	Number of patients with adverse events	Adverse events defined as implant loss, infection, haematoma, seroma, skin necrosis in all cohorts	3 months
Primary	Number of patients with adverse events	Adverse events defined as implant loss, infection, haematoma, seroma, skin necrosis in all cohorts	12 months
Secondary	Aesthetic outcome measured by Photographic assessment	Photographic assessment	12 months
Secondary	BREAST-Q questionnaire score	Patient-reported outcome measures using the BREASTQ questionnaire	30 days
Secondary	BREAST-Q questionnaire score	Patient-reported outcome measures using the BREASTQ questionnaire	12 months