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Immediate Postmastectomy Breast Reconstruction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LifeCell
ClinicalTrials.gov Identifier:
NCT00619762
First received: January 11, 2008
Last updated: April 7, 2013
Last verified: April 2013
History of Changes
  Purpose

This prospective, multicenter, open-label study will assess the clinical outcomes of the LTM product in three planned analyses. The primary objective of this study is to prospectively assess the clinical outcomes associated with the use of LTM in two-stage (expander then permanent implant) immediate post-mastectomy breast reconstruction.


Condition Intervention
Breast Cancer
 Device: LTM - a porcine-based surgical mesh

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter, Prospective, Open-Label Study to Assess the Clinical Outcomes of LTM Use in Two-Stage Breast Reconstruction Immediately Post Mastectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by LifeCell:

Primary Outcome Measures:
  • Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix [ Time Frame: At the time of expander/implant exchange (Stage II), ] [ Designated as safety issue: No ]
    Evaluation of 3 histology parameters, fibroblast infiltration, immune cell response & revascularization, expressed as frequency distributions. Samples evaluated for presence of fibroblasts (cellularity), neovascularization & immune cell response using 4 pt scale. Fibroblast Infiltration: 1=None,2=Few,sparse,3=Moderate,4=Dense. Revascularization:1=None,2=Few randomly dispersed capillaries,3=Moderate; mostly homogenous distribution of new vessels,4=Significant,uniformly distributed vessels; both capillaries and arterioles. Immune Cell response: 1= None,2=Few,normal healing response,3=Moderate,4=Significant;above expected presence for healing. 4 high power(HP)fields reviewed & if uniform in appearance/cellular distribution, 4 considered representative of sample as a whole. If non-uniform distribution observed, 3 HP fields of "sparse or light" distribution & 3 HP fields of dense distribution counted & results averaged. Tissue sample then assessed for overall acellularity & expressed as %.


Secondary Outcome Measures:
  • Severity of Local Inflammation at and Around the Surgical Site [ Time Frame: Postoperative Day 7, 14, 21, 30 days ] [ Designated as safety issue: Yes ]
    The Inflammatory response was evaluated by each of the four cardinal signs: erythema, edema, pain and heat, using standard scales for the evaluation of each sign and inflammation as a whole was assessed using a model (AIR Score) which took into account the scores assigned to each of the four signs. A mean score is provided at each timepoint.The minimum total possible score is 4 (less inflamation) and the maximum total possible score is 8 (more inflammation).


Biospecimen Retention:   Samples Without DNA

Tissue sample


Enrollment: 17
Study Start Date: October 2007
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: LTM - a porcine-based surgical mesh
    Use of LTM to support weak and/or absent soft tissue to facilitate immediate breast reconstruction postmastectomy
Detailed Description:

nothing to add

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

women undergoing two-stage immediate breast reconstruction following a skin sparing mastectomy will be recruited from up to ten (10) participating centers

Criteria

Inclusion Criteria:

  • A candidate for immediate, two-stage breast reconstruction using LTM following a skin sparing mastectomy
  • An ASA Physical Status Classification5 of 1 or 2 (see App I)
  • Estimated life expectancy > 1 year

Exclusion Criteria:

  • Clinically significant systemic disease
  • Received inductive chemo-therapy within 2 months prior to mastectomy or radiation therapy to the region at any time
  • Predicted excised breast mass of >750 gms
  • Co-morbid factors which predispose to postoperative infection, such as insulin dependent diabetes, smoking, chronic steroid use, malnourishment, or co-existent infection
  • Need for tissue flap in addition to expander
  • History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction
  • Enrollment or plans to enroll in another clinical trial during this study that would affect the patient's safety or results of this trial
  • Any of the conditions identified within the labeled contraindications, i.e. sensitivity to porcine derived products or polysorbate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619762

Locations
United States, District of Columbia
Washington, District of Columbia, United States
United States, Illinois
Chicago, Illinois, United States
United States, New York
Great Neck, New York, United States
United States, Pennsylvania
Willow Grove, Pennsylvania, United States
United States, Virginia
McLean, Virginia, United States
Sponsors and Collaborators
LifeCell
Investigators
Study Director: Michael Franz, MD LifeCell
  More Information

No publications provided

Responsible Party: LifeCell
ClinicalTrials.gov Identifier: NCT00619762     History of Changes
Other Study ID Numbers: LFC2007.01.01
Study First Received: January 11, 2008
Results First Received: December 19, 2012
Last Updated: April 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by LifeCell:
Breast reconstruction

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

ClinicalTrials.gov processed this record on May 19, 2013