Tissue Engineering

This research aims to evaluate the effectiveness of using a 3D scan to create personalized ostomy appliances for people with an ostomy. The study focuses on whether a 3D scan of the stoma can reduce leakages and improve quality of life compared to standard care. Ostomy appliances collect waste from the stoma but often cause complications such as skin irritation, leaks, and infections, which impact patients' daily lives. Participants will have their stoma scanned with a 3D scanner to create a detailed digital model. This model is then edited and used to produce a personalized ostomy appliance by modifying standard appliances with a laser cutter. The study involves two 2-week periods where participants use their usual ostomy appliance first, then the personalized 3D-printed appliance. The personalized appliances are designed with input from an ostomy nursing team to ensure proper fit based on each patient's body and stoma. During the 4-week study, participants will complete daily symptom diaries and weekly quality of life surveys conducted over the phone. Researchers will track leak incidents, the number of appliances used, and overall patient satisfaction. The study includes ongoing monitoring through electronic surveys requiring internet and device access. Total participation lasts about one month, with safety and quality of life as key measures.

Researchers are developing a platform to study soft tissue sarcomas (STS) using patient-derived xenografts (PDX) and 2D/3D cell cultures. This research addresses the challenge that current preoperative radiotherapy and systemic treatments are not uniformly effective across the diverse sarcoma subtypes. The study aims to better understand the response of different sarcoma types to therapies, which is difficult due to the rarity and variety of the disease. The study involves obtaining tumor material from patients with confirmed intermediate to high grade STS through a single tumor biopsy or tumor sampling during surgery. This fresh tumor material will be used to create PDX models in mice and 2D/3D cell cultures. Researchers will examine the growth and passage possibilities of these models and study their sensitivity to radiotherapy and chemotherapy over set timeframes ranging from weeks to two years. Participants will provide consent and undergo tumor biopsy or surgery for tissue collection. The study will track the success rate of tumor material implantation in mice and the development of cell culture models. These models will serve as tools for future research on anti-sarcoma therapies. Safety and adherence to follow-up are monitored to ensure reliable data. The total study duration includes short-term assessments and longer-term observation up to two years.

Researchers are evaluating the safety and effectiveness of the Symani Surgical System in microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery. This observational study aims to assess the device's performance in real-world settings, focusing on the rate of successful vessel connection in the first surgical attempt and the absence of device-related adverse events. Participants will receive standard surgical care using the Symani Surgical System, which offers articulated, interchangeable instruments designed for open microsurgery procedures. The study includes patients undergoing free tissue transfer of the breast or extremities and those having lymphovenous anastomosis surgery for lymphedema. During the trial, participants will have their surgical procedures assessed and may complete questionnaires if undergoing lymphedema procedures. Throughout the study, researchers will monitor the safety and effectiveness of the device by evaluating intraoperative vessel patency and tracking any adverse events up to 30 days after surgery. Participants will be asked to allow access to their medical information, attend follow-up visits, and complete all study procedures and questionnaires. The total participation covers the surgery period and a 30-day post-surgery follow-up to ensure comprehensive safety and outcome monitoring.

Researchers are evaluating the safety profile of OviTex PRS, a reinforced tissue matrix device, in patients who have previously undergone implant-based breast reconstruction. This observational study includes both retrospective and prospective data and focuses on women aged 18 to 75 years who received either pre-pectoral or sub-pectoral breast implants using OviTex PRS. The study aims to understand overall safety and device-specific safety to help guide future studies on effectiveness. The study involves patients who had immediate or two-stage unilateral or bilateral implant-based breast reconstruction using OviTex PRS devices, either permanent or resorbable. The reconstruction could have been performed in the sub-pectoral or pre-pectoral position. This multi-center study includes patients who have completed their initial and, if applicable, exchange surgeries. Some participants may also take part in a prospective portion that includes returning for in-person visits and photograph completion. Participants will be followed for safety outcomes up to 24 months after OviTex PRS implantation. Researchers will collect data on the occurrence of relevant adverse events, time to expander or implant exchange, intraoperative fill volumes and visits, and aesthetic assessments using the Telemark Breast Score and Rainbow Scale. Hospitalization length of stay at the time of procedure will also be recorded. The study monitors participant adherence and safety throughout this period, providing important insights into the device's use in breast reconstruction.

Researchers are evaluating the use of an acellular collagen matrix to improve wound healing after guided bone regeneration (GBR) procedures in patients who need increased bone volume in the jaw before dental implant placement. This study compares healing outcomes between patients whose wound is closed with the acellular matrix versus those who receive traditional surgical closure without it. The study focuses on early wound healing and aims to assess whether the acellular matrix helps prevent shallow vestibulum formation and reduces the need for additional surgeries. During the GBR procedure, bone grafting material is placed in the jawbone defect and covered with a barrier membrane. When the membrane is exposed due to limited tissue coverage, the acellular matrix may be placed over it to aid healing. Patients receive either the acellular matrix covering or standard surgical closure without the matrix, based on their dental surgeon's judgment. Standard postoperative care including antibiotics, pain control, and antiseptic mouthwash is provided. The study collects additional clinical and radiographic measurements before and after surgery, along with patient-reported experience data. Participants will have follow-up visits at 8-10 days, 6-8 weeks, and 4-6 months after surgery, during which wound healing will be assessed through clinical exams, CBCT scans, and implant stability checks. The study will measure healing scores and ridge dimension changes over time. Each visit may last about 40 minutes longer than routine appointments due to research-related assessments. The total observation period lasts up to 4-6 months, ending around the time of implant placement surgery.

Researchers are studying the best cementation methods and resin cement materials to improve the long-term success of aesthetic dental restorations, specifically porcelain veneers and direct composite restorations for front teeth. The study aims to compare two types of resin cements, Panavia Veneer LC and universal Panavia V5, in terms of marginal defects and discoloration. It will also evaluate patient satisfaction using the Orofacial Esthetic Scale (OES) after 1-year and 3-year follow-up periods. Participants will receive either porcelain veneers or direct composite restorations as aesthetic treatments. Porcelain veneers involve preparing the front upper teeth with a 0.5mm deep facial surface reduction and cementing laboratory-made veneers using two different cements for comparison. Digital impressions will be taken with an intraoral scanner, and veneers will be fabricated using CAD/CAM technology. Direct composite restorations will be created with digital modeling and injectable composite materials. Each patient will have two veneers cemented with each type of cement to allow direct comparison. During the study, researchers will monitor restoration condition, including ceramic fractures, cracks, retention loss, and discoloration. They will also assess the health of supporting teeth, checking for secondary caries or endodontic issues, as well as periodontal health through probing and gum evaluation. Patient satisfaction will be measured through questionnaires. Follow-ups will occur at 6 months, 1 year, and 3 years to observe outcomes and any complications. The total participation time varies according to these follow-ups.

Researchers are monitoring the effectiveness and safety of Autologous Fat Transfer (AFT) with pre-expansion as a method for full breast reconstruction in female breast cancer patients. This multicenter, prospective cohort study follows the BREAST trial and aims to evaluate quality of life, aesthetic outcomes, complications, oncological safety, and cost-effectiveness of AFT. All participants will receive AFT in this observational study. Participants will undergo breast reconstruction using Autologous Fat Transfer combined with an external expansion device. This procedure is offered to women who have had or will have a mastectomy, including preventive mastectomy. The study focuses on assessing various outcomes over several years, with particular attention to quality of life and aesthetic results at two years, and oncological safety up to five years after treatment. During the study, participants will be monitored for breast-related quality of life, aesthetic results, any complications, oncological safety, and the cost-effectiveness of the procedure. These outcomes will be assessed through regular follow-ups and evaluations over a period of two to five years. The study is led by Maastricht University Medical Center and aims to provide comprehensive information on this breast reconstruction method.

Researchers are studying autologous epidermal cell transplantation to help repair large, deep wounds caused by severe burns. This approach addresses the challenge of limited normal skin available for grafting in patients with extensive burns. Traditional skin grafting methods require multiple procedures and have limited expansion, leading to longer healing times and increased scarring. This research evaluates a new technique that expands a small piece of a patient's own skin cells in the lab to create larger grafts for wound repair, aiming to improve healing and reduce complications. The treatment involves taking small pieces of the patient's skin and rapidly growing the epidermal cells in the lab by 1000 to 5000 times over 2 to 3 weeks. These cultured epidermal cell membranes are then combined with expanded or allogeneic dermis grafts to cover large wounds. This method aims to shorten the time for graft integration, increase survival of the grafts, and reduce scarring. It offers a potential solution for patients with limited skin available for traditional grafts, especially those with very large and deep burns. Participants will be patients with wounds covering 30% or more of their body surface area that require at least two weeks to heal. Researchers will evaluate the success of the grafts by measuring the take rate of the cultured epidermal autografts after 4 weeks and monitor for any serious adverse events up to 52 weeks after treatment. The study involves careful monitoring of wound healing, safety, and long-term outcomes to assess this innovative skin repair method. Total participation duration and follow-up details are based on these outcome timelines.

Researchers are studying patients who have undergone reconstructive surgery on their upper or lower limbs using an anterolateral thigh flap. The study aims to monitor these patients after surgery to better detect flap failure, a complication caused by blood flow problems. This observational pilot study focuses on combining traditional clinical assessments with continuous tissue oxygenation measurements using a near-infrared spectroscopy (NIRS) device called FORE-SIGHT ELITE. The goal is to find preliminary data on tissue oxygenation cut-off values that may indicate flap failure. During the study, patients will be monitored using the current gold standard methods, which include checking the flap's skin color, temperature, tissue turgor, capillary refill time, and Doppler techniques. Alongside these, continuous tissue oxygenation will be measured with the FORE-SIGHT ELITE device, with sensors placed at both the flap and donor sites after surgery. These oxygenation readings will be blinded to patients and nursing staff during the five-day monitoring period. Patients will stay overnight in the Post Anesthetic Care Unit (PACU) and then transfer to a regular ward, where clinical checks will continue. Participants' clinical assessments will be performed hourly during the first 24 hours and regularly thereafter, including vital signs monitoring. Nurses will notify surgeons if clinical signs suggest flap problems. After five days, researchers will analyze the stored NIRS data comparing patients with flap failure to those without. The study will also perform a retrospective time-to-event analysis in patients with flap failure over about one year to better understand tissue oxygenation trends. This monitoring aims to improve early detection of flap failure and guide timely treatment.

Researchers are investigating the effect of mixing allogenic bone graft with xenograft, compared to mixing autologous bone graft with xenograft, for rebuilding deficient maxillary (upper jaw) ridges. The study focuses on guided bone regeneration in patients who have insufficient bone in the maxillary ridge for dental implant placement. It aims to see if the allogenic-xenograft mixture is as effective as the autologous-xenograft mixture in terms of bone ridge dimensions and quality of new bone formed. The trial compares two groups: one receiving a 1:1 mix of xenograft and allogenic bone graft chips, and the other getting a 1:1 mix of xenograft and autologous bone particles harvested from the mandibular ramus (lower jaw). A full-thickness flap is raised to access the ridge, the bone is prepared by decortication, and the grafts are applied and covered with a collagen membrane secured by tacks. The surgical site is closed with resorbable sutures. Both groups receive preoperative and 6-month postoperative cone beam CT scans to measure bone changes. Follow-up visits occur frequently for the first month and then monthly for three months. Participants undergo clinical and radiographic examinations before surgery to confirm eligibility and oral health. After six months, a second surgery collects bone biopsies for histological analysis and places dental implants. Researchers measure horizontal bone gain, ridge height, new bone formation, and residual graft material at six months. Patients receive antibiotics, anti-inflammatory medication, and antiseptic mouth rinse post-surgery, with instructions to avoid trauma to the area. The study lasts at least six months with detailed monitoring of bone regeneration and healing.