Breast CancerNCT00619762

Immediate Postmastectomy Breast Reconstruction (Strattice Breast)

An observational study of Breast Cancer, run by LifeCell at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: LTM - a porcine-based surgical mesh
Type of treatment: Medical device
How many people: 17 participants
Where: 5 sitesUnited States
Study dates: Oct 2007to Dec 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Study site
Chicago, Illinois
Study site
Great Neck, New York
Study site
McLean, Virginia
Study site
Washington D.C., District of Columbia
Study site
Willow Grove, Pennsylvania

Other trials in United States

About this study

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

Read the detailed description

nothing to add

Conditions: Breast Cancer
Being tested: LTM - a porcine-based surgical mesh
Keywords: Breast reconstruction
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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 %.
Measured: At the time of expander/implant exchange (Stage II),

Secondary outcomes (1)

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).
Measured: Postoperative Day 7, 14, 21, 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Dec 2009

First posted21 Feb 2008 (estimated)
Study startOct 2007
Primary completionOct 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00619762
Sponsor's protocol ID: LFC2007.01.01
Status last verified: Oct 2016
First submitted: 11 Jan 2008
Last updated: 8 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Prospective, Open-Label Study to Assess the Clinical Outcomes of LTM Use in Two-Stage Breast Reconstruction Immediately Post Mastectomy
ClinicalTrials.gov ID: NCT00619762
Acronym / sponsor ID: LFC2007.01.01
Conditions: Breast Cancer
Keywords: Breast reconstruction
Study type: Observational
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: LifeCellIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Oct 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 21 Feb 2008 (estimated)
Results: Posted 15 May 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

nothing to add

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: women undergoing two-stage immediate breast reconstruction following a skin sparing mastectomy will be recruited from up to ten (10) participating centers

Key inclusion criteria (3 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LTM - a porcine-based surgical meshUse of LTM to support weak and/or absent soft tissue to facilitate immediate breast reconstruction postmastectomy	Device	–

Primary outcome

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 %.

1 secondary outcome

Severity of Local Inflammation at and Around the Surgical Site
Time frame: Postoperative Day 7, 14, 21, 30 days

Results and safety

Results posted to the registry on 15 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LTM - Porcine Acellular Dermal Matrix in Breast Reconstruct	17	14

Primary outcome: Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix

Time frame: At the time of expander/implant exchange (Stage II),. Number. Unit: percentage of breasts

Measure	Treatment Arm n = 17
Fibroblast Infiltration Percent = None	0
Fibroblast Infiltration Percent = Few	82.8
Fibroblast Infiltration Percent = Moderate	17.2
Fibroblast Infiltration Percent=Significant (dense	0
Immune Cell Response Percent = None	3.4
Immune Cell Response Percent = Few	13.7
Immune Cell Response Percent = Moderate	10.3
Immune Cell Response Percent = Significant	72.4

Population analysed: All implanted patients enrolled in the study were included in the analysis

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from day of implantation through the 12 month visit. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Arm	3 of 17 (17.6%)	2 of 29 (6.9%)	Not reported

Limitations and caveats (from the sponsor): Small number of subjects and breasts analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Franz, MD study director

LifeCell

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by LifeCell at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix (time frame: At the time of expander/implant exchange (Stage II),). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00619762.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.