Impact of ADM in Reduction of Surgical Complexity of Breast Reconstructions With Implants (Nava)

NCT01853436 | Terminated

• 1 other identifier: LFC 2012.04.01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to demonstrate that acellular dermal matrix, Strattice™ Reconstructive Tissue Matrix, can reduce the surgical complexity and post-operative pain of breast reconstructions with implants by avoiding one more surgical step in the operating room.

Conditions

Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction

Keywords

Breast Cancer; Reconstructive Tissue Matrix; Acellular Dermal Matrices (ADM)

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  At month 36 post-implant placement

Secondary Outcomes (2)

• Post operative sensation at Postoperative

  At Post-op Days 14, 30 and at Months 6, 12, 24, and 36 post implant placement

• Quality of life pre-operatively and at post operative

  At month 6,12,24, and 36 post-implant placement

Other Outcomes (7)

• Safety endpoints: evaluated by the number and type of complications that may occur.

  At 6, 12, 24 and 36 months post-implant placement

• Rate of capsular contracture at post operative

  At month 6,12,24 and 36.

• Surgeon's evaluation of aesthetic outcome via photographs pre operatively

  At month 6,12,24,and 36 post-implant placement

Study Arms (2)

Single stage reconstructions

EXPERIMENTAL

as defined for use in the Experimental arm

Device: Strattice™ Reconstructive Tissue Matrix

Two stage breast reconstructions

OTHER

CONTROL: standard two stage breast reconstructions without Acellular dermal matrices (ADM), in patients who are clinically suitable candidates for reconstruction with Acellular dermal matrices(ADM)based single stage reconstruction technique. Reconstructions with Strattice™ Reconstructive Tissue Matrix

Device: Strattice™ Reconstructive Tissue Matrix

Interventions

Strattice™ Reconstructive Tissue Matrix DEVICE

Experimental arm: Device: Strattice Reconstructive Tissue Matrix Unilateral or bilateral mastectomy. Immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant with ADM, single stage reconstruction technique. Control arm: Device: no device. Immediate breast tissue expander/implant based reconstruction with a two-stage reconstruction technique.

Single stage reconstructions; Two stage breast reconstructions

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A study patient may be included if she:
• Has planned to undergo a unilateral or bilateral mastectomy and have small to medium size breasts (predicted breast implant size maximally 500 gms), with none or moderate (Grade 1 or 2) ptosis, and healthy, sufficiently thick, well-vascularized skin flaps anticipated by the surgeon.
• Is a clinically suitable candidate for immediate reconstruction with ADM based single stage reconstruction technique (as defined for use in the Experimental arm).
• Is female, ≥18 years of age.
• 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.
• Is in good health other than breast pathology and is suited to general anesthesia and planned treatments.
• 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.

You may not qualify if:

• A study patient is excluded from participation to the study if she:
• Has undergone breast radiation treatment and/or be preoperatively evaluated to require radiation treatment to the breast area during the course of the study.
• Has collagen-vascular, connective tissue, or uncorrectable bleeding disorders as determined clinically by the PI.
• Has a BMI that is ≥ 35.
• Has any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.
• Has an autoimmune disease, an immune deficiency, or is on immune suppression drugs other than any other current treatment for breast cancer.
• Currently has an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit.
• Is pregnant, or lactating.
• 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).
• Has an abscess or infection at the time of surgery.
• Has undergone previous breast surgery with the exception of breast biopsy, cyst removal, and lumpectomy.
• 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).
• Has a known pork allergy or is sensitive to polysorbate.

Sponsors & Collaborators

• LifeCell: lead

Study Sites (1)

Fondazione IRCCS Instituto Nazionale dei Tumori

Milan, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andrea Spano, MD

  Fondazione IRCCS Instituto Nazionale dei Tumori

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 15, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 25, 2017

Record last verified: 2017-05

Locations

IT (1)