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Breast Reconstruction With Acellular Dermal Matrix in the Setting of Breast Cancer Treatment

This study has been completed.
Sponsor:
Collaborators:
Karolinska Institutet
LifeCell
Information provided by (Responsible Party):
Fredrik Lohmander, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT02061527
First received: February 11, 2014
Last updated: August 16, 2017
Last verified: August 2017
  Purpose
To evaluate breast reconstruction with implants using biological mesh (Strattice™) in the setting of breast cancer treatment.

Condition Intervention Phase
Breast Cancer Procedure: Reconstruction with ADM. Procedure: Skin or nipple sparing mastectomy Procedure: Reconstruction with implant Procedure: Total submuscular coverage Procedure: Partial submuscular coverage Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate Breast Reconstruction With or Without the Use of Acellular Dermal Matrix: A Randomized Controlled Multicenter Study

Resource links provided by NLM:


Further study details as provided by Fredrik Lohmander, Karolinska University Hospital:

Primary Outcome Measures:
  • The primary endpoint of this study is number of unplanned/ unanticipated surgical breast procedures. Other endpoints in the trial will be secondary. [ Time Frame: 24 months ]
    Follow-up time after primary surgery is 24 months.


Secondary Outcome Measures:
  • Aesthetic outcome [ Time Frame: 24 months ]
    To measure aesthetic outcome between the two study groups using a 6- point scale. The evaluation will be done by three independent groups consisting of lay people, professionals (breast/ plastic surgeons) and patient evaluation. The aesthetic evaluation will be based on the pre and postoperative photos.

  • Complications [ Time Frame: 24 months ]
    To measure any difference between the two study groups in complication rates.

  • Number of surgical procedures [ Time Frame: 24 months ]
    To compare the total number of surgical procedures (planned or unplanned) between the two study groups).

  • Cost-Benefit analysis [ Time Frame: 24 months ]
    A cost-benefit analysis comparing the cost for an IBR with implant without ADM, vs. IBR with ADM (Strattice™) during a 24 months follow-up time.

  • Quality of Life [ Time Frame: 24 months ]
    Measure Quality of Life in both groups, using the EORTC QLQ-C30 (Generic tool), EORTC-BR23 (Breast cancer specific tool), EORTC-BRR (Specific for breast reconstruction).


Enrollment: 120
Actual Study Start Date: April 2014
Study Completion Date: May 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Breast reconstruction with ADM
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.
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.
Other Names:
  • Strattice
  • ADM
  • Implant
  • Immediate breast reconstruction
  • Acellular dermal matrix
  • Mastectomy
  • Breast cancer
  • Direct-to-implant
  • Expander
  • Breast reconstruction
Procedure: Skin or nipple sparing mastectomy
Mastectomy for invasive or pre-invasive breast cancer
Other Names:
  • Mastectomy
  • Skin sparing mastectomy
  • Nipple sparing mastectomy
  • Acellular dermal matrix
  • Immediate breast reconstruction
  • ADM
  • Breast cancer
  • Strattice
  • Implant
Procedure: Reconstruction with implant
Immediate breast reconstruction with implant
Other Names:
  • Implant
  • Mastectomy
  • Acellular dermal matrix
  • Direct-to-implant
  • Immediate breast reconstruction
  • ADM
  • Strattice
  • Breast cancer
Procedure: Partial submuscular coverage
Implant based breast reconstruction with partial submuscular coverage
Active Comparator: Breast reconstruction without ADM
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 mastectomy
Mastectomy for invasive or pre-invasive breast cancer
Other Names:
  • Mastectomy
  • Skin sparing mastectomy
  • Nipple sparing mastectomy
  • Acellular dermal matrix
  • Immediate breast reconstruction
  • ADM
  • Breast cancer
  • Strattice
  • Implant
Procedure: Reconstruction with implant
Immediate breast reconstruction with implant
Other Names:
  • Implant
  • Mastectomy
  • Acellular dermal matrix
  • Direct-to-implant
  • Immediate breast reconstruction
  • ADM
  • Strattice
  • Breast cancer
Procedure: Total submuscular coverage
Implant based breast reconstruction with total submuscular coverage

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02061527

Locations
Sweden
Falun Hospital, Department of Breast Surgery
Falun, Sweden
Capio S:t Gorans Hospital
Stockholm, Sweden
Karolinska University Hospital
Stockholm, Sweden
Södersjukhuset AB
Stockholm, Sweden
United Kingdom
Oxford University Hospitals
Oxford, United Kingdom
Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
LifeCell
Investigators
Principal Investigator: Fredrik Lohmander, MD Karolinska Institutet
  More Information

Responsible Party: Fredrik Lohmander, Fredrik Lohmander MD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02061527     History of Changes
Other Study ID Numbers: FL/KUH-ADM-LFC-2014
Study First Received: February 11, 2014
Last Updated: August 16, 2017

Keywords provided by Fredrik Lohmander, Karolinska University Hospital:
ADM
Strattice
Breast reconstruction
Immediate breast reconstruction
IBR
Acellular dermal matrix
Biological mesh
Randomized controlled trial
RCT
Breast cancer
Implants
Mastectomy
Direct-to-implant

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

ClinicalTrials.gov processed this record on September 19, 2017