Status:
TERMINATED
Impact of ADM in Reduction of Surgical Complexity of Breast Reconstructions With Implants (Nava)
Lead Sponsor:
LifeCell
Conditions:
Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction
Eligibility:
FEMALE
18+ years
Phase:
NA
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 reconstruction...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01853436
Start Date
March 1 2013
End Date
July 1 2017
Last Update
May 25 2017
Active Locations (1)
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1
Fondazione IRCCS Instituto Nazionale dei Tumori
Milan, Italy