Clinical Research Directory

Leica Microsystems Sponsored Study to Collect and Confirm Clinical Data on the Performance of the GLOW800 Device When Used in Accordance With Its Intended Use.

This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW800 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope. The study evaluates fluorescence visualization and image quality during standard surgical procedures in the cerebral vascular area and plastic and reconstructive surgery. It is a non-interventional, observational study conducted in routine care settings across multiple European sites.

A Retrospective Assessment of OviTex PRS (OviTex)

The objective of this retrospective-prospective, observational study is to evaluate the safety profile overall and within two device types of OviTex PRS in previous pre-pectoral or sub-pectoral implant-based breast reconstructions.

Effect of Platelet-Rich Plasma on Graft Uptake and Postoperative Outcomes in Full-Thickness Skin Grafting of Face and Neck

This clinical study aims to evaluate whether applying platelet-rich plasma (PRP), a substance made from a person's own blood, can improve the success of full-thickness skin grafts used to treat facial and neck wounds. Skin grafting is a common reconstructive technique for covering wounds caused by injuries, burns, surgeries, or other conditions. However, skin grafts sometimes do not heal well, leading to complications such as graft failure, infection, or delayed healing, especially in delicate areas like the face and neck. Platelet-rich plasma contains special healing components called growth factors that may help tissues heal faster and better. These growth factors support new blood vessel formation, reduce swelling, and promote healthy skin regeneration. In this study, participants will be randomly assigned to one of two groups. One group will receive skin grafts along with PRP applied to the wound and graft site, while the other group will receive standard grafting without PRP. The study will measure how much of the graft survives and integrates into the wound (called "graft uptake") on the 7th day after surgery. It will also assess other early outcomes such as signs of redness (erythema), infection, or blood collection under the graft (hematoma). The hypothesis is that using PRP will lead to better graft healing and fewer complications than using skin grafts alone. The results of this study may help improve recovery and reduce the need for further procedures in patients with facial and neck skin defects.

Exploring Optimal Photographic Parameters for Standardized Facial Aesthetics Analysis

The main objective of this research is to identify the focal length that allows the most accurate and reproducible 2D assessment of facial aesthetics, without introducing significant distortion. Ultimately, this will enable the establishment of a standardized photography protocol for maxillofacial and aesthetic surgery, facilitating harmonized pre- and post-operative assessments and improving communication between healthcare providers and patients.

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.