Immediate Postmastectomy Breast Reconstruction (Strattice Breast)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00619762
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : May 15, 2013
Last Update Posted : November 8, 2016
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Brief Summary:
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 or disease Intervention/treatment
Breast Cancer Device: LTM - a porcine-based surgical mesh

Detailed Description:
nothing to add

Study Type : Observational
Actual Enrollment : 17 participants
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
Study Start Date : October 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix [ Time Frame: At the time of expander/implant exchange (Stage II), ]
    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 :
  1. Severity of Local Inflammation at and Around the Surgical Site [ Time Frame: Postoperative Day 7, 14, 21, 30 days ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00619762

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
Study Director: Michael Franz, MD LifeCell

Responsible Party: LifeCell Identifier: NCT00619762     History of Changes
Other Study ID Numbers: LFC2007.01.01
First Posted: February 21, 2008    Key Record Dates
Results First Posted: May 15, 2013
Last Update Posted: November 8, 2016
Last Verified: October 2016

Keywords provided by LifeCell:
Breast reconstruction