NCT02061527

Brief Summary

To evaluate breast reconstruction with implants using biological mesh (Strattice™) in the setting of breast cancer treatment.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable breast-cancer

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

3 years

First QC Date

February 11, 2014

Last Update Submit

April 23, 2018

Conditions

Breast Cancer

Keywords

ADMStratticeBreast reconstructionImmediate breast reconstructionIBRAcellular dermal matrixBiological meshRandomized controlled trialRCTBreast cancerImplantsMastectomyDirect-to-implant

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint of this study is number of unplanned/ unanticipated surgical breast procedures. Other endpoints in the trial will be secondary.

    Follow-up time after primary surgery is 24 months.

    24 months

Secondary Outcomes (5)

  • Aesthetic outcome

    24 months

  • Complications

    24 months

  • Number of surgical procedures

    24 months

  • Cost-Benefit analysis

    24 months

  • Quality of Life

    24 months

Study Arms (2)

Breast reconstruction with ADM

EXPERIMENTAL

Implant based Breast Reconstruction with ADM. Both arms will undergo skin or nipple sparing mastectomy and immediate breast reconstruction with implants. Patients in group B with ADM and partial submuscular coverage.

Procedure: Reconstruction with ADM.Procedure: Skin or nipple sparing mastectomyProcedure: Reconstruction with implantProcedure: Partial submuscular coverage

Breast reconstruction without ADM

ACTIVE COMPARATOR

Breast reconstruction without ADM. Both arms will undergo skin or nipple sparing mastectomy and immediate breast reconstruction with implant. Patients in group B will be reconstructed with implant and total submuscular coverage.

Procedure: Skin or nipple sparing mastectomyProcedure: Reconstruction with implantProcedure: Total submuscular coverage

Interventions

Reconstruction with ADM.PROCEDURE

If the patient wishes to undergo immediate implant based reconstruction, and meets the selection criteria for entering the study, she is randomly selected to be treated according to Group A or Group B. Group A (no intervention) will be reconstructed with expander or anatomical gel implant without ADM, using complete muscle coverage. Group B (Intervention) will be reconstructed with expander or anatomical gel implant using partial muscle coverage in conjunction with ADM.

Also known as: Strattice, ADM, Implant, Immediate breast reconstruction, Acellular dermal matrix, Mastectomy, Breast cancer, Direct-to-implant, Expander, Breast reconstruction
Breast reconstruction with ADM
Skin or nipple sparing mastectomyPROCEDURE

Mastectomy for invasive or pre-invasive breast cancer

Also known as: Mastectomy, Skin sparing mastectomy, Nipple sparing mastectomy, Acellular dermal matrix, Immediate breast reconstruction, ADM, Breast cancer, Strattice, Implant
Breast reconstruction with ADMBreast reconstruction without ADM
Reconstruction with implantPROCEDURE

Immediate breast reconstruction with implant

Also known as: Implant, Mastectomy, Acellular dermal matrix, Direct-to-implant, Immediate breast reconstruction, ADM, Strattice, Breast cancer
Breast reconstruction with ADMBreast reconstruction without ADM
Total submuscular coveragePROCEDURE

Implant based breast reconstruction with total submuscular coverage

Breast reconstruction without ADM
Partial submuscular coveragePROCEDURE

Implant based breast reconstruction with partial submuscular coverage

Breast reconstruction with ADM

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with invasive or pre-invasive (in situ) breast cancer, planned for immediate breast reconstruction post-skin sparing or nipple sparing mastectomy (unilateral or bilateral)
  • Patient agrees to participate in study and to sign an informed consent form
  • Able and willing to return for all scheduled and required study visits

You may not qualify if:

  • Is a smoker (patient having quit at least 4 weeks prior surgery can be included)
  • BMI \<18 or \> 30
  • Previous radiation therapy to the region at any time
  • Insulin-dependent diabetes or any immune deficiency requiring immunosuppressant use such as cortisone or biological therapies
  • Predicted implant size \<200 or \>600 ml per investigator assessment
  • Allergy to porcine
  • Pregnancy or lactating
  • Current enrollment or plans to enroll in another clinical trial unless a retrospective study
  • Neoadjuvant treatment with chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Falun Hospital, Department of Breast Surgery

Falun, Sweden

Location

Capio S:t Gorans Hospital

Stockholm, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Södersjukhuset AB

Stockholm, Sweden

Location

Oxford University Hospitals

Oxford, United Kingdom

Location

Related Publications (2)

  • Lohmander F, Lagergren J, Johansson H, Roy PG, Brandberg Y, Frisell J. Effect of Immediate Implant-Based Breast Reconstruction After Mastectomy With and Without Acellular Dermal Matrix Among Women With Breast Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2127806. doi: 10.1001/jamanetworkopen.2021.27806.

    PMID: 34596671DERIVED

  • Lohmander F, Lagergren J, Johansson H, Roy PG, Frisell J, Brandberg Y. Quality of life and patient satisfaction after implant-based breast reconstruction with or without acellular dermal matrix: randomized clinical trial. BJS Open. 2020 Oct;4(5):811-820. doi: 10.1002/bjs5.50324. Epub 2020 Aug 6.

    PMID: 32762012DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Plastic Surgery ProceduresstratticeDrug ImplantsMastectomyTissue Expansion DevicesMammaplastyMastectomy, Subcutaneous

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeDelayed-Action PreparationsDosage FormsPharmaceutical PreparationsProstheses and ImplantsEquipment and SuppliesSurgical EquipmentCosmetic TechniquesTherapeutics

Study Officials

  • Fredrik Lohmander, MD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fredrik Lohmander MD

Study Record Dates

First Submitted

February 11, 2014

First Posted

February 13, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

April 24, 2018

Record last verified: 2018-04

Locations

GB(1)SE(4)