Comparing Two Different Surgical Techniques for Breast Reconstruction

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04716959
• Collaborator: (none)
• Enrollment: 0
• Locations: 7
• Arms: 2
• Actual Duration (Months): 10.9
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Reconstruction	Procedure: Prepectoral Prosthetic Breast Reconstruction; Procedure: Subpectoral Prosthetic Breast Reconstruction	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial of Prepectoral Versus Subpectoral Prosthetic Breast Reconstruction
• Actual Study Start Date: Jan 14, 2021
• Actual Primary Completion Date: Dec 13, 2021
• Actual Study Completion Date: Dec 13, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prepectoral Prosthetic Breast Reconstruction	Procedure: Prepectoral Prosthetic Breast Reconstruction; The prepectoral approach involves placing the tissue expander on top of the pectoralis muscle.
Active Comparator: Subpectoral Prosthetic Breast Reconstruction	Procedure: Subpectoral Prosthetic Breast Reconstruction; The subpectoral approach involves placing the tissue expander under the pectoralis muscle with or without acellular dermal matrix (ADM).

Outcome Measures

Primary Outcome Measures

1. major perioperative complications [90 days]

   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.

Secondary Outcome Measures

1. minor complications [90 days]

   Minor complication for tissue expanders is defined as: Seroma: clinically significant non-infected fluid collection requiring either needle aspiration or drain replacement

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering BaskingRidge (Consent and Followup)	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth (Consent and Followup)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (Consent and Followup )	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Commack (Consent and Followup)	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester (Consent and Followup)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau (Consent and Followup)	Rockville Centre	New York	United States	11553

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center

Investigators

• Principal Investigator: Evan Matros, MD, MMSc, MPH, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT04716959
• Other Study ID Numbers: 20-565
• First Posted: Jan 20, 2021
• Last Update Posted: Jan 3, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Memorial Sloan Kettering Cancer Center: Prosthetic; Breast tissue expander; 20-565

Study Results

No Results Posted as of Jan 3, 2022