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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00639106
First Posted: March 19, 2008
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Michigan
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
March 12, 2008
March 19, 2008
April 4, 2017
March 2008
March 2018   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00639106 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • To examine if the use of Alloderm will impact both chronic breast pain and sensory morbidity. [ Time Frame: conclusion of the study ]
  • To evaluate patient satisfaction following postmastectomy, tissue expander-implant reconstruction with and without the use of Alloderm. [ Time Frame: 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. [ Time Frame: conclusion of the study ]
Same as current
Not Provided
Not Provided
 
Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial
The Use of Alloderm in Two-Stage, 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Breast Cancer
  • Procedure: Alloderm, Questionnaires
    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
  • Procedure: Without ALLODERM, Questionnaires
    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
  • Experimental: A
    Expander Placement WITH Alloderm
    Intervention: Procedure: Alloderm, Questionnaires
  • Active Comparator: B
    Expander Placement WITHOUT Alloderm
    Intervention: Procedure: Without ALLODERM, Questionnaires
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
98
March 2018
March 2018   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
21 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00639106
08-024
Not Provided
Not Provided
Not Provided
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
  • University of Michigan
  • University of North Carolina, Chapel Hill
Principal Investigator: Joseph Disa, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
April 2017

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