Immediate Postmastectomy Breast Reconstruction

Breast Cancer Clinical Trial

Official title:

A Multicenter, Prospective, Open-Label Study to Assess the Clinical Outcomes of LTM Use in Two-Stage Breast Reconstruction Immediately Post Mastectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619762
• Other study ID #: LFC2007.01.01
• Status: Completed
• Phase: N/A
• First received: January 11, 2008
• Last updated: April 7, 2013
• Start date: October 2007
• Est. completion date: December 2009

Study information

• Verified date: April 2013
• Source: LifeCell
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

nothing to add

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• LTM - a porcine-based surgical mesh
Use of LTM to support weak and/or absent soft tissue to facilitate immediate breast reconstruction postmastectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LifeCell

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix	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 %.	At the time of expander/implant exchange (Stage II),	No
Secondary	Severity of Local Inflammation at and Around the Surgical Site	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).	Postoperative Day 7, 14, 21, 30 days	Yes