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

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

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.

Study Overview

• Status: Terminated
• Conditions: Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction
• Intervention / Treatment: Device: Strattice™ Reconstructive Tissue Matrix

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Fondazione IRCCS Instituto Nazionale Dei Tumori

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Single stage reconstructions; as defined for use in the Experimental arm	Device: Strattice™ Reconstructive Tissue Matrix; 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.
OTHER: Two stage breast reconstructions; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative sensation at Postoperative	Patients' subjective experience of sensation in the reconstructed breast as estimated by the subjective scale. In the experimental arm, this datum will be assessed at the POD 14 visit after the single stage implant (SSI) + ADM procedure; in the control arm\ this datum will be assessed at the POD 14 visit after the first stage and again POD 14 after the second surgical stage (TE/Implant exchange). The questionnaire will also be completed at Months 6, 12, 24 and 36.	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	Patients' QoL, including emotional and satisfaction status, will be assessed before the reconstruction procedure and at POD 30 after single stage implant (SSI) + ADM in the experimental group via the Short Form (SF)-36 questionnaire; and at POD 30 after TE/Implant exchange in the control group.	At month 6,12,24, and 36 post-implant placement

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoints: evaluated by the number and type of complications that may occur.	Safety will be assessed continuously for the study period.	At 6, 12, 24 and 36 months post-implant placement
Rate of capsular contracture at post operative	The incidence of grade III and IV of Baker capsular contracture rates will be assessed after reconstruction.	At month 6,12,24 and 36.
Surgeon's evaluation of aesthetic outcome via photographs pre operatively	Photographs, taken at follow up visits, will be assessed for aesthetic outcome after reconstruction. Conventional Anthropometric distance measurements will be assessed, including nipple-sternal notch, nipple-nipple and nipple-infra-mammary fold after reconstruction.	At month 6,12,24,and 36 post-implant placement
Costs related to in-hospital stay and devices.	Overall cost of In-hospital stay (crude and including revision procedures) and device costs will be assessed.	At 6, 12, 24 and 36 months post-implant placement
Duration of post operative drainage.	Duration of drain time from placement to removal and total drainage per day will be assessed after all surgical procedures where drains are used.	At Post-op Day 30
Total operating time	Operating time in minutes (in the control arm, operating time of the first and the second surgical stages will be recorded separately).	At Day of Surgery and Day of Expander/Implant exchange
Acute inflammatory response	Concatenated score as well as scores from each of the subscales will be examined.	At Day of Discharge, Post-op Days 14 and 30

Collaborators and Investigators

• Sponsor: LifeCell
• Investigators: Principal Investigator: Andrea Spano, MD, Fondazione IRCCS Instituto Nazionale Dei Tumori

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2013
• Primary Completion (ACTUAL): April 1, 2017
• Study Completion (ANTICIPATED): July 1, 2017

Study Registration Dates

• First Submitted: May 7, 2013
• First Submitted That Met QC Criteria: May 10, 2013
• First Posted (ESTIMATE): May 15, 2013

Study Record Updates

• Last Update Posted (ACTUAL): May 25, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Breast Cancer; Reconstructive Tissue Matrix; Acellular Dermal Matrices (ADM)
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: LFC 2012.04.01