The use of SERI for soft tissue support in breast reduction surgery.
Research type
Research Study
Full title
A prospective open-label study to investigate the clinical efficacy of the soft tissue support SERI in breast reduction or mastopexy.
IRAS ID
149961
Contact name
Jen Boston
Contact email
Sponsor organisation
Guys and St Thomas' NHS Foundation Trust
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
Recurrent ptosis and pseudoptosis in which the nipple is located above the mammary fold but the breast itself is flattened and droppy, is common post-mastopexy (breast uplift). Numerous techniques have been described to prevent this and to provide longer lasting results. SERI scaffold is a biocompatible and reabsorbable material which has been used as a soft tissue support in implant breast reconstructions. The objective of this study is to evaluate the efficacy of SERI as a soft tissue support during breast reduction and mastopexy operations. This is a single centre study and all patients who are listed for breast reduction/mastopexy procedures during the study period will be invited to participate. Patients will have SERI inserted into breast tissue to provide support to the lower aspect of the breast intra-operatively. Clinical outcome data will be collected post-operatively at 2 weeks,3, 6, 12 months from the index procedure and one visit per year up to 5 years from surgery to assess the efficacy of SERI in preventing recurrent ptosis and pseudoptosis.
REC name
London - Stanmore Research Ethics Committee
REC reference
14/LO/1987
Date of REC Opinion
17 Dec 2014
REC opinion
Further Information Favourable Opinion