Status:
WITHDRAWN
Comparing Two Different Surgical Techniques for Breast Reconstruction
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Breast Reconstruction
Eligibility:
FEMALE
21-60 years
Phase:
PHASE3
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04716959
Start Date
January 14 2021
End Date
December 13 2021
Last Update
January 3 2022
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
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