Clinical Research Directory

Electrical Stimulation for Improving Postoperative Breast Sensation

Described as the "Angelina Jolie Effect", rates of prophylactic mastectomy with immediate implant-based reconstruction are increasing dramatically as more women with genetic predisposition towards breast cancer are seeking surgical prevention. Advances in surgical techniques allow for the creation of an aesthetically pleasing postoperative breast mound; however, a common complaint is the lack of sensation to the skin and nipple of the reconstructed breast due to injury and stretch of the sensory nerves. Numbness of the breast, nipple, and areola is an unnatural feeling for the patient, as well as a potential risk for injury or burns as the woman is unable to feel pain. Our laboratory has previously shown that electrical stimulation (ES) is an effective way of improving nerve regeneration after injury to the nerves of the upper and lower extremities. Proven to improve motor outcomes following carpal and cubital tunnel release and sensation following injury to the digital nerves, this technique is a likely mechanism of restoring sensation of the breast as well. In this study, we will follow thirty women undergoing prophylactic skin-sparing mastectomy with immediate implant-based reconstruction. At the time of surgery, patients will be randomly assigned ES to either the right or left breast. That breast will be reconstructed first and stimulated for one hour while the other breast is reconstructed. At the completion of the case, all wires will be removed. We will test sensation (tactile, temperature, 2-point discrimination, sharp/dull discrimination, and protective sensation) prior to surgery then again at 6, 12, 18, and 24 months following surgery to evaluate the effects of ES on sensory return. Patients will be provided with a survey to assess return of erogenous sensation.

Motiva Flora® Aesthetic Breast Recon® Clinical Study

The present study will be based on a hybrid breast reconstruction approach with initial skin expansion using the Motiva Flora® Tissue Expander followed by a serial fat grafting session and a final step that includes the placement of a permanent breast implant Ergonomix2®.

NPWT Reduction Mammaplasty

In this prospective, randomized, split-body control trial, we aim to compare complications, patient-reported outcomes, and cost differentials following reduction mammaplasty with prophylactic closed incision negative pressure wound therapy versus standard adhesive dressing.

A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery

The purpose of this study is to learn whether there is a superior fat processing method in terms of graft retention in breast reconstruction after mastectomy.

Impact of Nipple Reconstruction in Mastectomized Patients Using Cross-Linked Hyaluronic Acid Injection.

This study evaluates the impact of hyaluronic acid (HA) injection for nipple projection following mastectomy, as a complement to areola micropigmentation. While micropigmentation is standard in nipple-areola complex (NAC) reconstruction, HA use remains novel, with limited data on psychosocial, sexual, and aesthetic outcomes. A sequential explanatory mixed-methods design will be used. In Phase 1, a randomized controlled trial will compare two groups: one receiving NAC micropigmentation alone (control) and the other receiving micropigmentation plus HA-based nipple projection (intervention). A total of 138 participants will be recruited at the Areolar Micropigmentation Unit of Germans Trias i Pujol University Hospital (Barcelona) over 36 months. Outcomes will include psychosocial and sexual well-being, satisfaction with breast and nipple appearance, and nipple projection, measured using the Spanish BREAST-Q, a custom satisfaction tool, and calipers. Phase 2 will involve a qualitative phenomenological study using semi-structured interviews with a purposive sample from the intervention group. Thematic analysis will explore body image, emotional and social well-being, and overall satisfaction, using NVivo software. This is the first study assessing HA nipple reconstruction by advanced practice nurses using validated patient-reported outcomes. While the BREAST-Q is appropriate, it may not fully capture emotional nuances, justifying qualitative exploration. HA durability is estimated at 6-9 months, but residual volume and satisfaction over time remain underexplored. HA's aesthetic footprint may allow reduced dosages in future applications. This minimally invasive technique may reduce the need for surgical nipple reconstruction. Conducting the procedure in a nurse-led setting is novel and may enhance patient-centered care and the role of nursing in post-mastectomy recovery. The study complies with the Declaration of Helsinki and Spanish biomedical regulations. Ethical approval was obtained. Participants will provide informed consent, and data will be anonymized and securely stored.

Options on the Breast Reconstruction Timing and Method After Removal of Polyacrylamide Hydrogel

Since polyacrylamide hydrogel (PAAG) was used in cosmetic surgery in 1997, about 30 million women have received PAAG injection for breast augmentation. Although the use of PAAG has been prohibited in most countries due to its myriad complications, a large number of symptomatic patients and asymptomatic patients have continued to seek medical advice. The strategy of repairing secondary breast deformities after PAAG removal has increasingly become a concern for both doctors and patients, but there is no standardized algorithm yet. The purpose of the present study was to perform a retrospective study to compare the safety and effectiveness of different reconstruction timing and method after removing the gel.

NovoX®Cup as Primary Dressing After Breast Reduction

Breast reduction is one of the most frequently performed plastic surgeries. Studies have shown that breast reduction surgery significantly improves the patients' suffering and leads to a better health-related quality of life.However, as in every surgery, there can be complications. Wound disorders, such as open wounds and skin loss account for the most commonly encountered postoperative complications. NovoX® Cup is a new single-use wound dressing that is shaped cupular in order to tightly adapt to the breast anatomy. It is internally coated with oxygen-enriched oil releasing reactive oxygen species and is free from active pharmaceutical ingredients. It is intended, among other indications, for the use in surgical wounds after oncological breast surgery, breast reconstruction and cosmetic breast surgery. In two studies, a total of 140 patients (surgical wounds after breast augmentation-mastopexy, mammary lesions) were treated successfully with NovoX® Cup and no product-related adverse events were reported.The claimed advantages sound promising but an advantage compared to established wound dressings such as sterile strips or tapes has still to be investigated. The aim of the following study is to compare the outcomes (postoperative complications, scar quality and patients' satisfaction) of breast reduction and application of the wound dressing NovoX® Cup in comparison to already established wound closure systems 2 weeks and 3 months after surgery.

Safety and Performance of Motiva® Sizers

The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures. The research will include 330 women, divided into two groups of 165 participants each (150 breast augmentation participants and 15 reconstruction participants). The Motiva® Sizer exposed group will consist of women who will undergo breast augmentation or reconstruction surgery with the use of Motiva® Sizer during the procedure, and a non-exposed group will consist of women who will undergo breast augmentation or reconstruction surgery without the use of Motiva® Sizer. This study will be conducted in Costa Rica. The main goal is to evaluate the safety and the performance of the Motiva® Sizer. To this end, the results of both groups will be compared in terms of surgical complications, surgeon's, and participant's satisfaction level as well as reoperation rates. After the augmentation or reconstruction surgery, participants will be scheduled for the following follow-up visits, (1) between 3 and 7 postoperative days, (2) between 3 and 6 postoperative weeks, (3) at 3 and (4) 6 postoperative months, and (5, 6 and 7) annually thereafter for a period of three consecutive years. In case any participant has an adverse event due to the procedure, and if required by the physician, an additional visit will be made to assess her, and this information as well as that of the scheduled visits should be recorded in the electronic data collection notebook.