Comparing Two Different Surgical Techniques for Breast Reconstruction

Breast Reconstruction Clinical Trial

Official title:

A Randomized Controlled Trial of Prepectoral Versus Subpectoral Prosthetic Breast Reconstruction

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04716959
• Other study ID #: 20-565
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 14, 2021
• Est. completion date: December 13, 2021

Study information

• Verified date: December 2021
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare two standard techniques for breast reconstruction-the prepectoral technique and the subpectoral technique. Again, the prepectoral technique involves putting a tissue expander on top of the pectoralis muscle, while the subpectoral technique involves putting a tissue expander under the pectoralis muscle.

The standard approach used at MSK is the subpectoral technique. This study will help researchers find out whether the subpectoral approach is better, the same as, or worse than the prepectoral approach. To decide which approach is better, the researchers will look at which technique causes fewer complications after surgery (for example, infection or the need for a second surgery). Researchers are also interested in seeing which approach causes less pain and use of pain medication after surgery.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 13, 2021
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• Women aged 21-60 years

• Planning to undergo immediate two stage prosthetic breast reconstruction with TE placement as the first stage.

• Planning to undergo unilateral or bilateral mastectomy.

• Planning to undergo nipple- or skin-sparing mastectomy.

• Mastectomy weight less than 800 grams.

• Adequate mastectomy skin perfusion or patients with adequate perfusion but nonviable mastectomy skin that can be excised (= 4 cm) at the defect margins with otherwise adequate perfusion.

Exclusion Criteria:

• Receipt of neoadjuvant chemotherapy for locally advanced breast cancer.

• Presence of preoperative axillary lymph node metastasis.

• Presence of intraoperative sentinel node positivity.

• History of radiotherapy.

• Current smoker.

• Planning to undergo direct-to-implant reconstruction.

• BMI >35.

• Prior sternotomy.

Related Conditions & MeSH terms

• Breast Reconstruction

Intervention

Procedure:
• Prepectoral Prosthetic Breast Reconstruction
The prepectoral approach involves placing the tissue expander on top of the pectoralis muscle.
• Subpectoral Prosthetic Breast Reconstruction
The subpectoral approach involves placing the tissue expander under the pectoralis muscle with or without acellular dermal matrix (ADM).

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering BaskingRidge (Consent and Followup)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack (Consent and Followup)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Consent and Followup)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Consent and Followup)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Consent and Followup )	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (Consent and Followup)	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major perioperative complications	90-day major complications for tissue expanders (i.e., infection, explantation, and reoperation for mastectomy flap necrosis): Infection: any event requiring restart of antibiotics (oral or intravenous) following completion of initial perioperative antibiotics or an admission to the hospital for cellulitis.; Explantation: need for tissue expander removal for any cause.; Reoperation: skin excision performed in either the clinic or the main operating room for mastectomy skin flap necrosis.	90 days
Secondary	minor complications	Minor complication for tissue expanders is defined as: Seroma: clinically significant non-infected fluid collection requiring either needle aspiration or drain replacement	90 days

External Links

•   Memorial Sloan Kettering Cancer Center