Clinical trial NCT01853436: Impact of ADM in Reduction of Surgical Complexity of Breast Reconstructions With Implants (Nava)
Official title: Impact of Acellular Dermal Matrix in Reduction of Surgical Complexity of Breast Reconstructions With Implants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction
Keywords: Breast Cancer
Reconstructive Tissue Matrix
Acellular Dermal Matrices (ADM)
Lead sponsor: LifeCell
Sponsor class: INDUSTRY
First posted: 2013-05-15
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: 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 (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.
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 is 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 breast biopsy, cyst removal, and lumpectomy.
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.

Primary outcomes:
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.
timeFrame: At month 36 post-implant placement
Secondary outcomes:
measure: Post operative sensation at Postoperative
timeFrame: At Post-op Days 14, 30 and at Months 6, 12, 24, and 36 post implant placement
measure: Quality of life pre-operatively and at post operative
timeFrame: At month 6,12,24, and 36 post-implant placement
Other outcomes:
measure: Safety endpoints: evaluated by the number and type of complications that may occur.
timeFrame: At 6, 12, 24 and 36 months post-implant placement
measure: Rate of capsular contracture at post operative
timeFrame: At month 6,12,24 and 36.
measure: Surgeon's evaluation of aesthetic outcome via photographs pre operatively
timeFrame: At month 6,12,24,and 36 post-implant placement
measure: Costs related to in-hospital stay and devices.
timeFrame: At 6, 12, 24 and 36 months post-implant placement
measure: Duration of post operative drainage.
timeFrame: At Post-op Day 30
measure: Total operating time
timeFrame: At Day of Surgery and Day of Expander/Implant exchange
measure: Acute inflammatory response
timeFrame: At Day of Discharge, Post-op Days 14 and 30
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Instituto Nazionale dei Tumori
Study officials:
affiliation: Fondazione IRCCS Instituto Nazionale dei Tumori
name: Andrea Spano, MD
role: PRINCIPAL_INVESTIGATOR
References: