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Completed

NCT Number: NCT00639106

Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Michigan Health System, Ann Arbor, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Alloderm, Questionnaires

Procedure

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.

Other names: 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

Without ALLODERM, Questionnaires

Procedure

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

Other names: 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

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.

    Time frame: conclusion of the study

Secondary outcomes

  1. 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.

    Time frame: conclusion of the study

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

    Time frame: conclusion of the study

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

    Time frame: conclusion of the study

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

    Time frame: conclusion of the study

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

    Time frame: conclusion of the study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • University of Michigan
  • University of North Carolina, Chapel Hill

Registry information

Official study title

The Use of Alloderm in Two-Stage, Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
Mar 19, 2008
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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