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The Use of Surgical Mesh in Pre-Pectoral Tissue Expander Breast Reconstruction
Trial Status: active
This early phase I trial evaluates surgical mesh assistance, particularly acellular dermal matrices (ADM) in pre-pectoral (above the chest muscle) tissue expander in patients undergoing breast reconstruction. One in eight women will develop breast cancer in their lifetime, causing both physical and psychological trauma due to invasive treatments and the distress associated with removal of a breast. Breast reconstruction after mastectomy has become a critical procedure for many women to restore psychological wellbeing, with implant-based reconstruction the most common approach. Different types of surgical mesh, such as ADM, are used during breast reconstruction. This trial may help researchers better understand whether ADM results in lower complication rates and better post-surgical appearance in patients undergoing breast reconstruction.
Inclusion Criteria
Patients ages 22-75 undergoing unilateral or bilateral immediate pre-pectoral breast reconstruction with tissue expander
Prophylactic and oncologic mastectomies are both acceptable
Nipple sparing and skin sparing mastectomies are both acceptable
Exclusion Criteria
Intraoperative assessment demonstrates unfavorable conditions (i.e. poor mastectomy skin flap thickness or viability) for immediate pre-pectoral reconstruction in any breast
Bilateral reconstruction patients undergoing contralateral submuscular reconstruction (i.e. left pre-pectoral and right submuscular)
Direct-to-implant reconstruction
Pregnancy
Delayed reconstruction (i.e. not during same surgery as mastectomy)
Additional locations may be listed on ClinicalTrials.gov for NCT05190978.
I. Demonstrate feasibility of an intra-operative randomization protocol for studying mesh assistance in immediate pre-pectoral tissue expander breast reconstruction and generate data to understand any patient refusals to participate in a randomized breast reconstruction study.
II. Generate preliminary data on the relative safety of performing immediate pre-pectoral breast reconstruction without mesh assistance compared to with mesh assistance.
III. Provide preliminary data on the aesthetic results of mesh devices versus no mesh in immediate pre-pectoral breast reconstruction using the validated BREAST-Q patient satisfaction questionnaire.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo immediate pre-pectoral breast reconstruction with tissue expanders covered by acelullar dermal matrix surgical mesh on study.
ARM II: Patients undergo immediate pre-pectoral breast reconstruction with tissue expanders on study.
Trial PhasePhase O
Trial Typetreatment
Lead OrganizationUCLA / Jonsson Comprehensive Cancer Center
