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Impact of Acellular Dermal Matrix in Reduction of Surgical Complexity of Breast Reconstructions With Implants

Phase 4
18 Years
Open (Enrolling)
Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction

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Trial Information

Impact of Acellular Dermal Matrix in Reduction of Surgical Complexity of Breast Reconstructions With Implants

This study is designed to compare the clinical outcomes of patients undergoing mastectomy
followed by a direct to implant breast reconstruction with Strattice™ Reconstructive Tissue
Matrix to patients undergoing a standard two-stage reconstruction without Strattice™ or any
other mesh or tissue flap.

Potential candidates for the study will be identified through routine practice. Women who
meet the inclusion and exclusion criteria will be invited to participate in the study. A
screening visit will take place maximally 30 days prior to surgery.

Randomization will occur maximally 7 days prior to the mastectomy procedure. As some women
may have to undergo bilateral mastectomy and reconstruction, the randomization scheme will
ensure that both breasts will be reconstructed with the same surgical approach.

The Day of Surgery consists of both a mastectomy and a breast reconstruction. The surgical
site and the breasts will be evaluated on the day of hospital discharge and at postoperative
days 14 and 30 for all patients after each hospital admission. During these visits, the
breasts will be examined and an Acute Inflammatory Assessment (AIR) will be completed. In
addition the breast flaps and incisions will be evaluated for signs of infection, seroma,
hematoma or skin necrosis.

Inclusion Criteria:

A study patient may be included if she:

1. Has planned to undergo a unilateral or bilateral mastectomy and have small to medium
size breasts (<750gm excised tissue anticipated by the surgeon), with none or
moderate (Grade 1 or 2) ptosis, and healthy, sufficiently thick, well-vascularized
skin flaps anticipated by the surgeon.

2. Is a clinically suitable candidate for immediate reconstruction with ADM based single
stage reconstruction technique (as defined for use in the Experimental arm).

3. Is female, ≥18 years of age.

4. Is willing to undergo immediate breast reconstruction with sub-pectoralis muscle
placement of a breast implant by either the Experimental (ADM based single stage) or
the Control (TE/Implant based two stage) techniques.

5. Is in good health other than breast pathology and are suited to general anesthesia
and planned treatments.

6. Understands and is willing to follow all aspects of the study protocol including
randomization and has signed and dated the approved Informed Consent Form prior to
any study-related procedures being performed.

Exclusion Criteria:

A study patient is excluded from participation to the study if she:

1. Has undergone breast radiation treatment and/or be preoperatively evaluated to
require radiation treatment to the breast area during the course of the study.

2. Has collagen-vascular, connective tissue, or uncorrectable bleeding disorders as
determined clinically by the PI.

3. Has a BMI that is ≥ 35.

4. Has any disease, including uncontrolled diabetes, which is clinically known to impact
wound healing ability.

5. Has an autoimmune disease, an immune deficiency, or is on immune suppression drugs
other than any other current treatment for breast cancer.

6. Currently has an alcohol/substance abuse problem or have had a relapse within 1 year
prior to screening visit.

7. Is pregnant, or lactating.

8. Has concomitant unrelated condition of breast/chest wall/skin that, as determined by
the PI, could affect the surgical outcome (e.g. significant chest wall abnormalities
including pectus excavatum or pectus carinatum).

9. Has an abscess or infection at the time of surgery.

10. Has undergone previous breast surgery with the exception of mastectomy, breast
biopsy, cyst removal, lumpectomy, mastopexy, reduction and/or augmentation.

11. Has had a prior soft tissue support device implanted in the breast or is
participating in another clinical trial with a breast related device (e.g. drains,
expanders, implants).

12. Has a known pork allergy or is sensitive to polysorbate.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Number of surgeries where a differentiation will be made between major and minor depending upon the requirement to enter the breast pocket under general anesthesia.

Outcome Description:

Total numbers of major and of minor surgeries for each patient during the full trial period and including any surgeries that the PI determines are clinically still necessary at the end of the trial period. Major procedures are defined as those involving the patient to be treated in the OR: re-entering the implant pocket; soft-tissue flaps not performed under local anesthesia; general anesthesia; or procedures requiring inpatient admission. Other procedures, including for instance CT-guided percutaneous drainage or breast fat grafting (lipofilling), are defined as minor procedures.

Outcome Time Frame:

At month 36 post-implant placement

Safety Issue:


Principal Investigator

Maurizio B Nava

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fondazione IRCCS Instituto Nazionale dei Tumori


Italy: Ethics Committee

Study ID:

LFC 2012.04.01



Start Date:

March 2013

Completion Date:

April 2016

Related Keywords:

  • Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction
  • Breast Cancer
  • Reconstructive Tissue Matrix
  • Acellular Dermal Matrices (ADM)
  • Breast Neoplasms