Back to results

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

Primary Purpose

Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction

Status

Terminated

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Strattice™ Reconstructive Tissue Matrix

About this trial

This is an interventional treatment trial for Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction focused on measuring Breast Cancer, Reconstructive Tissue Matrix, Acellular Dermal Matrices (ADM)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Fondazione IRCCS Instituto Nazionale dei Tumori

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Single stage reconstructions

Two stage breast reconstructions

Arm Description

as defined for use in the Experimental arm

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT01853436

First Posted

May 7, 2013

Last Updated

May 23, 2017

Sponsor

LifeCell

1. Study Identification

Unique Protocol Identification Number

NCT01853436

Brief Title

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

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Terminated

Why Stopped

Lifecell became part of Allergan; company deciscion

Study Start Date

March 2013 (Actual)

Primary Completion Date

April 2017 (Actual)

Study Completion Date

July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LifeCell

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single stage reconstructions

Arm Type

Experimental

Arm Description

as defined for use in the Experimental arm

Arm Title

Two stage breast reconstructions

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Strattice™ Reconstructive Tissue Matrix

Intervention Description

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.

Primary Outcome Measure Information:

Title

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.

Description

Time Frame

At month 36 post-implant placement

Secondary Outcome Measure Information:

Title

Post operative sensation at Postoperative

Description

Time Frame

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

Title

Quality of life pre-operatively and at post operative

Description

Time Frame

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

Other Pre-specified Outcome Measures:

Title

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

Description

Safety will be assessed continuously for the study period.

Time Frame

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

Title

Rate of capsular contracture at post operative

Description

The incidence of grade III and IV of Baker capsular contracture rates will be assessed after reconstruction.

Time Frame

At month 6,12,24 and 36.

Title

Surgeon's evaluation of aesthetic outcome via photographs pre operatively

Description

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.

Time Frame

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

Title

Costs related to in-hospital stay and devices.

Description

Overall cost of In-hospital stay (crude and including revision procedures) and device costs will be assessed.

Time Frame

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

Title

Duration of post operative drainage.

Description

Duration of drain time from placement to removal and total drainage per day will be assessed after all surgical procedures where drains are used.

Time Frame

At Post-op Day 30

Title

Total operating time

Description

Operating time in minutes (in the control arm, operating time of the first and the second surgical stages will be recorded separately).

Time Frame

At Day of Surgery and Day of Expander/Implant exchange

Title

Acute inflammatory response

Description

Concatenated score as well as scores from each of the subscales will be examined.

Time Frame

At Day of Discharge, Post-op Days 14 and 30

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrea Spano, MD

Organizational Affiliation

Fondazione IRCCS Instituto Nazionale dei Tumori

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fondazione IRCCS Instituto Nazionale dei Tumori

City

Milan

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs