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Evaluating Outcomes of Immediate Breast Reconstruction (POBRAD-M)

NCT02557906 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 209

Last updated 2018-03-13

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms
  • Breast Diseases

Interventions

PROCEDURE

Breast reconstruction - implant and an ADM (SurgiMend)

Skin or nipple sparing mastectomy and immediate breast reconstruction with implants and SurgiMend

PROCEDURE

Breast reconstruction- autologous tissue

Skin or nipple sparing mastectomy and immediate breast reconstruction with autologous tissue

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

Sponsors & Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

    collaborator OTHER

  • Integra LifeSciences Corporation

    collaborator INDUSTRY

  • King's College London

    lead OTHER

Principal Investigators

  • Michael Douek, MD FRCS · King's College London

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-01-31
Completion
2020-01-31

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02557906 on ClinicalTrials.gov