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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

January 11, 2008
April 7, 2013
October 2007
October 2009   (final data collection date for primary outcome measure)
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 %.
Not Provided
Complete list of historical versions of study NCT00619762 on ClinicalTrials.gov Archive Site
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).
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Not Provided
Not Provided
 
Immediate Postmastectomy Breast Reconstruction
A Multicenter, Prospective, Open-Label Study to Assess the Clinical Outcomes of LTM Use in Two-Stage Breast Reconstruction Immediately Post Mastectomy

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.

nothing to add
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Tissue sample
Non-Probability Sample

women undergoing two-stage immediate breast reconstruction following a skin sparing mastectomy will be recruited from up to ten (10) participating centers
Breast Cancer
Device: LTM - a porcine-based surgical mesh
Use of LTM to support weak and/or absent soft tissue to facilitate immediate breast reconstruction postmastectomy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
December 2009
October 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00619762
LFC2007.01.01
No
LifeCell
LifeCell
Not Provided
Study Director: Michael Franz, MD LifeCell
LifeCell
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP