NCT00639106

Brief Summary

Following mastectomy (removal of your breast), reconstruction of your breast(s) can be performed using tissue expanders and implants. At the same operation as your mastectomy, a tissue expander is put under the skin and muscles of your chest. Following your surgery, the tissue expander is gradually filled with salt water over a period of months. Once the expander is filled to the size of your new breast, a second operation is performed. At this time, the tissue expander is removed and a permanent breast implant is placed. This is a standard procedure. We are interested in learning about the use of AlloDerm in breast reconstruction. AlloDerm can be used instead of some of your own chest muscles, in order to cover and protect a tissue expander. We want to know if the use of AlloDerm can decrease your pain or discomfort after surgery and after the filling of your tissue expander. AlloDerm is made from human tissue. When AlloDerm is made all the cells that could cause your body to reject it are removed. When it is placed in your chest, your own cells will then grow into the AlloDerm, causing it to act like the muscle it is replacing. In this study, you will either have reconstruction with AlloDerm or without AlloDerm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_3 breast-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2008

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 3, 2018

Status Verified

October 1, 2018

Enrollment Period

10.6 years

First QC Date

March 12, 2008

Last Update Submit

October 2, 2018

Conditions

Breast Cancer

Keywords

Breast expanderBreast reconstructionimplants08-024

Outcome Measures

Primary Outcomes (1)

  • whether using Alloderm to create the inferior-medial portion of the expander pocket will decrease patient-reported pain in both the immediate, post-operative period and during the expansion phase.

    conclusion of the study

Secondary Outcomes (5)

  • To examine if the use of Alloderm will decrease patient-reported sensory morbidity in both the immediate, post-operative period and during the expansion phase.

    conclusion of the study

  • To evaluate whether the use of Alloderm in tissue expander/implant reconstruction affects the rate of postoperative expansion and in-hospital narcotic use.

    conclusion of the study

  • To examine if the use of Alloderm will impact both chronic breast pain and sensory morbidity.

    conclusion of the study

  • To evaluate patient satisfaction following postmastectomy, tissue expander-implant reconstruction with and without the use of Alloderm.

    conclusion of the study

  • To examine the effect of Alloderm on the overall aesthetic outcome, including the formation of capsular contracture, following tissue expander/implant reconstruction.

    conclusion of the study

Study Arms (2)

A

EXPERIMENTAL

Expander Placement WITH Alloderm

Procedure: Alloderm, Questionnaires

B

ACTIVE COMPARATOR

Expander Placement WITHOUT Alloderm

Procedure: Without ALLODERM, Questionnaires

Interventions

Without ALLODERM, QuestionnairesPROCEDURE

A standard, sub-muscular pocket dissection will be performed in the patients assigned to the control group. No Alloderm will be used.

Also known as: Questionnaires administered prior to mastectomy, on Post-op Day #1, prior to the first, second, and third injection and following completion of expansion will take approximately 20 minutes, to complete., It is expected that the panel of questionnaires administered at baseline (prior to mastectomy), and at 6 and 12 months following the exchange procedure will take approximately 45 minutes
B
Alloderm, QuestionnairesPROCEDURE

All patients will undergo placement of a temporary tissue expander immediately following mastectomy.Patients will undergo the surgical creation of an expander pocket using implantable Alloderm.

Also known as: Questionnaires administered prior to mastectomy, on Post-op Day #1, prior to the first, second, and third injection and following completion of expansion will take approximately 20 minutes, to complete., It is expected that the panel of questionnaires administered at baseline (prior to mastectomy), and at 6 and 12 months following the exchange procedure will take approximately 45 minutes
A

Eligibility Criteria

Age21 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who undergo immediate, postmastectomy, tissue expander/implant reconstruction
  • Patients ≥ 21 and ≤ 75 years of age

You may not qualify if:

  • Patient refusal
  • Patients who will undergo any of the following:
  • Single-stage implant reconstruction
  • Combined autogenous tissue expander/implant reconstruction
  • Patients with a history of prior irradiation
  • Patients with a history of prior surgery with breast implants
  • Patients with a history of prior axillary lymph node dissection
  • Patients who are pregnant
  • The following eligibility will be confirmed at the time of surgery.
  • Patients who are deemed intraoperatively by the attending surgeon to have significant mastectomy flap ischemia.
  • Patients who have an axillary lymph node dissection at the time of mastectomy (Patients undergoing sentinel lymph biopsy are eligible)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of North Carolina School of Medicine

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

  • McCarthy CM, Lee CN, Halvorson EG, Riedel E, Pusic AL, Mehrara BJ, Disa JJ. The use of acellular dermal matrices in two-stage expander/implant reconstruction: a multicenter, blinded, randomized controlled trial. Plast Reconstr Surg. 2012 Nov;130(5 Suppl 2):57S-66S. doi: 10.1097/PRS.0b013e31825f05b4.

    PMID: 23096987DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

AllodermSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Joseph Disa, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2008

First Posted

March 19, 2008

Study Start

March 1, 2008

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

October 3, 2018

Record last verified: 2018-10

Locations

US(3)