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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by LifeCell
Sponsor:
Information provided by (Responsible Party):
LifeCell
ClinicalTrials.gov Identifier:
NCT01853436
First received: May 7, 2013
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction
Device: Strattice™ Reconstructive Tissue Matrix
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact of Acellular Dermal Matrix in Reduction of Surgical Complexity of Breast Reconstructions With Implants

Resource links provided by NLM:


Further study details as provided by LifeCell:

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. [ Time Frame: At month 36 post-implant placement ] [ Designated as safety issue: No ]
    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 [ Time Frame: At Post-op Days 14, 30 and at Months 6, 12, 24, and 36 post implant placement ] [ Designated as safety issue: No ]
    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 surgical site infection (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 [ Time Frame: At month 6,12,24, and 36 post-implant placement ] [ Designated as safety issue: No ]
    Patients' QoL, including emotional and satisfaction status, will be assessed before the reconstruction procedure and at POD 30 after surgical site infection (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),


Other Outcome Measures:
  • Safety endpoints: evaluated by the number and type of complications that may occur. [ Time Frame: At 6, 12, 24 and 36 months post-implant placement ] [ Designated as safety issue: Yes ]
    Safety will be assessed continuously for the study period.

  • Rate of capsular contracture at post operative [ Time Frame: At month 6,12,24 and 36. ] [ Designated as safety issue: No ]
    The incidence of grade III and IV of Baker capsular contracture rates will assessed after reconstruction.

  • Surgeon's evaluation of aesthetic outcome via photographs pre operatively [ Time Frame: At month 6,12,24,and 36 post-implant placement ] [ Designated as safety issue: No ]
    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.

  • Costs related to in-hospital stay and devices. [ Time Frame: At 6, 12, 24 and 36 months post-implant placement ] [ Designated as safety issue: No ]
    Overall cost of In-hospital stay (crude and including revision procedures) and device costs will be assessed.

  • Duration of post operative drainage. [ Time Frame: At Post-op Day 30 ] [ Designated as safety issue: No ]
    Duration of drain time from placement to removal and total drainage per day will be assessed after all surgical procedures where drains are used.

  • Total operating time [ Time Frame: At Day of Surgery and Day of Expander/Implant exchange ] [ Designated as safety issue: No ]
    Operating time in minutes (in the control arm, operating time of the first and the second surgical stages will be recorded separately).

  • Acute inflammatory response [ Time Frame: At Day of Discharge, Post-op Days 14 and 30 ] [ Designated as safety issue: No ]
    Concatenated score as well as scores from each of the subscales will be examined.


Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single stage reconstructions
Reconstructions with Strattice™ Reconstructive Tissue Matrix
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. Two-stage reconstruction:TE/Implant based two stage technique.
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
Unilateral or bilateral mastectomy. Immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant with ADM,single stage reconstruction technique. Two-stage reconstruction:TE/Implant based two stage technique.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 (<750gm excised tissue anticipated by the surgeon), 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 are 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 mastectomy, breast biopsy, cyst removal, lumpectomy, mastopexy, reduction and/or augmentation.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01853436

Contacts
Contact: Sandra van Guldener +31 6 12504695 sguldene@lifecell.com
Contact: Michael Franz 908 947 1104 mfranz@lifecell.com

Locations
Italy
Fondazione IRCCS Instituto Nazionale dei Tumori Recruiting
Milan, Italy
Contact: Maurizio B. Nava    +39-02-23902258    Maurizio.nava@istitutotumori.mi.it   
Principal Investigator: Maurizio B. Nava         
Sponsors and Collaborators
LifeCell
Investigators
Principal Investigator: Maurizio B Nava Fondazione IRCCS Instituto Nazionale dei Tumori
  More Information

No publications provided

Responsible Party: LifeCell
ClinicalTrials.gov Identifier: NCT01853436     History of Changes
Other Study ID Numbers: LFC 2012.04.01
Study First Received: May 7, 2013
Last Updated: December 11, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by LifeCell:
Breast Cancer
Reconstructive Tissue Matrix
Acellular Dermal Matrices (ADM)

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 30, 2014