Trial record 2 of 57 for:    Mammaplasty | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Karolinska University Hospital
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: April 3, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]
    Follow-up time after primary surgery is 24 months.


Secondary Outcome Measures:
  • Aesthetic outcome [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To measure any difference between the two study groups in complication rates.

  • Number of surgical procedures [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To compare the total number of surgical procedures (planned or unplanned) between the two study groups).

  • Cost-Benefit analysis [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 120
Study Start Date: April 2014
Estimated Study Completion Date: November 2017
Estimated 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

Detailed Description:

OBJECTIVES: To evaluate the outcome of immediate breast reconstruction with Acellular Dermal Matrix (Strattice™), measuring safety, effectiveness, and costs. The primary outcome measure is number of unplanned surgical procedures.

STUDY DESIGN: A prospective randomized multicenter trial. One hundred and twenty patients with breast cancer will be enrolled into the study. Study duration will be two years from time of primary cancer surgery.

TRIAL DESIGN This is a randomized controlled multicenter trial, comparing IBR without (group A) and with (group B) the use of ADM. Participants eligible for the study are patients with breast cancer, planned for mastectomy, who wishes IBR with implants. Each participant is individually randomized to either be reconstructed using implants with total submuscular coverage (A) or reconstruction with ADM and partial muscle coverage (B).

Method of assigning patients to treatment groups:

After signing and dating the informed consent the patient is entered into the study. If all inclusion and none of the exclusion criteria are full filled, the patient will be randomized to group A or group B.

TREATMENT/ INTERVENTION The decision and treatment plan advocating mastectomy is based on multi disciplinary conference (MDT), and the diagnosis of invasive or pre-invasive (in situ) breast cancer is made on triple assessment. 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 will be reconstructed with expander or anatomical gel implant without ADM, using complete muscle coverage. Group B will be reconstructed with expander or anatomical gel implant using partial muscle coverage in conjunction with ADM.

Randomization at enrollment is made with regard to the use of ADM or not, so both expander and direct-to-implant techniques will be utilized in both groups, depending on the quality of skin flaps at time of surgery.

RANDOMIZATION TYPE Patients will be allocated to treatment according to permuted block technique. The actual randomization will be performed using computer based system located at Regional Cancer Center (RCC) within Karolinska Institutet. In this system inclusion and exclusion criteria will be automatically checked before patients are randomized to treatment. The randomization process will be stratified for the participating units.

STATISTICAL METHODS The main endpoint to be analyzed is the proportion of unplanned reoperations after the initial breast reconstruction. The difference in proportions between the two groups will be presented as a difference in proportion together with a 95% confidence interval. Differences will be tested using Fishers Exact Test. Logistic regression will be used to take into account possible confounding factors.

STUDY MANAGEMENT Data recording: The investigators will ensure that all data from patient visits are entered promptly in ink, in the case report forms (CRF). The principal investigator must sign the final CRF page to attest to the accuracy and completeness of the data. The data from the CRFs are then transferred to a database.

Monitoring and audit: At periods not exceeding 3 months, centers will be contacted to discuss the progress of the trial, with the purpose to verify CRF data against source records for accuracy of data recording and collection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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

Contacts
Contact: Fredrik Lohmander, MD +46709370721 fredrik.lohmander@ki.se
Contact: Jakob Lagergren, MD PhD jakob.lagergren@karolinska.se

Locations
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Fredrik Lohmander, MD    +46709370721    fredrik.lohmander@ki.se   
Principal Investigator: Jakob Lagergren, MD PhD         
Sub-Investigator: Jan Frisell, Professor         
Principal Investigator: Fredrik Lohmander, MD         
Södersjukhuset AB Recruiting
Stockholm, Sweden
Contact: Catharina Eriksen, MD PhD       catharina.eriksen@sodersjukhuset.se   
Contact: Fuat Celebiolgu, MD PhD       fuat.celebioglu@sodersjukhuset.se   
Principal Investigator: Catharina Eriksen, MD PhD         
Capio S:t Gorans Hospital Recruiting
Stockholm, Sweden
Contact: Catharina Eriksen, MD PhD       catharina.eriksen@capiostgoran.se   
Contact: Sophie Norenstedt, MD PhD       sophie.norenstedt@capiostgoran.se   
Principal Investigator: Catharina Eriksen, MD PhD         
Danderyds Sjukhus Not yet recruiting
Stockholm, Sweden
Contact: Fredrik Lohmander, MD    +46709370721    fredrik.lohmander@ki.se   
United Kingdom
Oxford University Hospitals Not yet recruiting
Oxford, United Kingdom
Contact: Pankaj G Roy, MD PhD       pankaj.roy@ouh.nhs.uk   
Principal Investigator: Pankaj G Roy, MD PhD         
Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
LifeCell
Investigators
Principal Investigator: Fredrik Lohmander, MD Karolinska Institutet
  More Information

No publications provided

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: April 3, 2014
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Karolinska University Hospital:
Breast reconstruction
Immediate breast reconstruction
ADM
Strattice
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 August 28, 2014