Clinical trials

Providing healthcare to homeless people is a key and challenging task, both for society as a whole and for medical and psychosocial professionals. It must be noted that the standard healthcare system is hardly used, or can only be used to an insufficient extent, by homeless people, and therefore does not comprehensively reach this group. One low-threshold and acceptance-oriented service outside the standard care system is the Johanniter-Hilfsmobil, which was established on June 3, 2024, as an innovative approach to healthcare for homeless people in Augsburg and will be scientifically examined in the following study. The aim is to compare acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter-Hilfsmobil with those of patients who attend the outpatient wound clinic at the Clinic for Vascular Surgery at Augsburg University Hospital. In addition, a saliva test will be carried out to estimate the amount and type of substance consumed, and a survey will be conducted among drug-dependent test subjects who present themselves either via the Johanniter-Hilfsmobil or via the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy, and Psychosomatics at Augsburg District Hospital. Another focus of research is the quantitative and qualitative analysis of the psychosocial living situation and environmental influences on users of the Johanniter-Hilfsmobil.

Surgical site infections are among the most frequent complications after abdominal surgery and are associated with impaired wound healing, prolonged hospital stay, additional treatments, and increased healthcare costs. Closure of the subcutaneous tissue before skin closure is commonly performed in abdominal surgery, but the available evidence supporting this practice remains limited and heterogeneous, particularly outside caesarean section surgery. The SUTURE trial is a prospective, randomized, patient- and assessor-blinded superiority trial evaluating whether subcutaneous tissue closure reduces the incidence of surgical site infections after abdominal surgery. Adult patients undergoing elective open or laparoscopically/robotically assisted abdominal surgery with an abdominal incision of at least 6 cm will be randomized intraoperatively after fascial closure to either subcutaneous tissue closure using interrupted Vicryl® 2-0 sutures or no subcutaneous tissue closure. The primary endpoint is the occurrence of surgical site infection according to CDC criteria grade I-II within 30 days after surgery. The trial aims to provide high-quality evidence on whether routine subcutaneous tissue closure should be recommended as a standardized wound closure strategy in abdominal surgery.

The aim of this BZKF project is to record the current care structure for breast cancer patients in order to use this as a basis for developing possible future models for improvement. The active involvement of representatives of regional and national patient organizations in the creation of a patient-based and patient-oriented survey ensures that the needs of patients are the focus. In addition to and in contrast to other projects, relevant questions are explicitly addressed not only to patients but also to physicians in order to identify and specify the interfaces between patient wishes/suggestions and to develop clinical consequences for care. The first objective is to survey the "current situation" by recording the current care structure for breast cancer. The focus is on the survey of both groups on patient-physician communication, time management and coping strategies. By planning the future harmonization of national data structures, the basis is created for the long-term goal of an improved "target", a concept developed jointly by physicians and patients for an improved communication and care structure that focuses on the patient.

Basal cell carcinoma (BCC) is the most common malignant skin tumour. The standard treatment is micrographically controlled surgery (MMS), which achieves high cure rates but requires considerable time and personnel. A key problem is the inadequate preoperative determination of tumour margins, which often leads to multiple cycles of excision. The aim of this multicentre, prospective, randomised controlled intervention study is to evaluate line-field confocal optical coherence tomography (LC-OCT) for preoperative margin determination in BCC within the framework of MMS. Research question: Can preoperative LC-OCT-assisted margin marking increase the efficiency of MMS by reducing the number of excision cycles required without compromising oncological safety? Methodology: Approximately 290 patients with histologically confirmed BCC will be enrolled at five German centres and randomly assigned to either standard MMS or MMS with upstream LC-OCT margin determination. In the intervention group, the excision margin will be specifically extended if a tumour is detected in the LC-OCT. Primary endpoint: Number of MMS cycles required to achieve R0 resection. Secondary endpoints: Total duration of surgery, size of surgical defect, cosmetic outcome (POSAS), patient satisfaction and stress, sensitivity and specificity of LC-OCT compared to histopathology. Significance: The study addresses the clinical conflict of objectives between complete tumour removal and maximum tissue preservation. Successful implementation could optimise MMS through modern imaging, conserve surgical resources and improve patient care in the long term.

A large proportion of radiological CT examinations require the intravenous administration of iodine-containing X-ray contrast medium. According to current guidelines, the amount required for CT examinations in the (portal) venous phase is calculated on the basis of body weight (e.g. 0.2-0.4 g iodine/kg body weight), but a standardized application dose of the contrast agent is often also used. In earlier studies, the investigators found that the iodine contrast in vessels and organs achieved with a standardized amount of contrast agent differs significantly between women and men. On average, women showed around 10% higher iodine contrast than men of the same height and weight. The investigators attribute these differences to physiological, sex-specific differences in blood volume. For example, the blood volume of a woman 175 cm tall and weighing 75 kg is approx. 400 ml less than that of a man of the same height and weight (approx. 4.6 vs. 5.0 l, calculated according to Nadler). Taking blood volume into account, sex was no longer a significant influencing factor in a retrospective cohort (n=274). The investigators would now like to investigate these results in a prospective study. For this purpose, two groups of patients with a clinical indication for a contrast-enhanced CT scan in the venous phase will be compared: 1. control group with regular weight-adjusted (n = 200) 2. study group with dosing according to blood volume (n = 200). The hypothesis is that the application scheme adapted to the blood volume leads to a more homogeneous contrasting of women and men. In order to quantify this effect, the iodine contrast values of both groups will be quantitatively analyzed, taking into account other influencing variables (height, weight). The investigators hope that this approach will reduce or even eliminate the observed sex-specific differences. This would lead to a sex-equal contrast based on an individualized amount of contrast medium.

Background: Between one-third and one-half of patients with bicuspid aortic valve (BAV) disease develop significant aortic regurgitation (AR) at a young age, leading to cardiomyopathy and heart failure. Aortic valve repair is an evolving and still underused strategy in BAV patients with AR. The lack of sufficient standardization remains the main limitation of current repair techniques, resulting in an increased risk of AR recurrence and reoperation. The most controversial issue is the stabilization of the BAV annulus. The CONTOUR trial aims to compare two different BAV annuloplasty concepts in a prospective randomized study. Methods: CONTOUR is a multicenter, randomized controlled trial designed to enroll 100 consecutive BAV patients with AR across four sites in Germany. BAV AR patients with an asymmetric configuration and without concomitant root aneurysm will be randomized 1:1 to undergo aortic valve repair using an internal HAART 200 annuloplasty device (i.e., INTERNAL group) (n=50) or external annuloplasty (i.e., double external ring annuloplasty) in the EXTERNAL group (n=50). 4D flow MRI will be performed preoperatively (t1), postoperatively at discharge (t2), and at 1-year follow-up (t3) for rater-blinded assessment of hemodynamic profiles (i.e., flow eccentricity) and regurgitation fraction at the MRI core-lab. Two hierarchically ordered primary endpoints will be considered: (1) postoperative reduction of flow eccentricity at hospital discharge and (2) regurgitation fraction (%) at 1-year follow-up. Discussion: The CONTOUR trial is designed to test the hypothesis that an internal annuloplasty device, creating a completely symmetric post-repair BAV geometry, achieves superior aortic valve repair outcomes compared to external annuloplasty. If our hypothesis is confirmed, our study will significantly influence aortic valve repair practice and contribute to the refinement of guideline recommendations in the management of BAV patients with AR.

The study is designed as international, prospective, minimal interventional study in cooperation with EUBREAST e.V. (European Breast Cancer Research Association of Surgical Trialists). Furthermore, it is planned to initiate a registry for postoperative breast seromas.

One treatment option of internal carotid artery stenosis is open surgical endarterectomy. The operation is frequently carried out under regional plexus anesthesia, allowing the patient to remain awake during the procedure. This approach offers the advantage of monitoring for neurological changes during carotid artery clamping, allowing the surgical team to immediately respond by placing a shunt to ensure cerebral perfusion. As a result, performing surgery under regional anesthesia provides therefor a benefit. However, for patients, the procedure, which can last up to two hours or longer in some cases, may pose a significant burden. The fixed position, inability to move, sterile drapes over the face, manipulation by the surgical team, and anxiety about potential complications are just a few of the factors that may distress patients during the operation. Increased sweating and reports of substantial subjective distress are not uncommon if the procedure is performed under local anesthesia. In many medical fields, devices and therapies are now being utilized to reduce patient stress in the perioperative setting. In procedures performed under local or regional anesthesia, such as in orthopedics or dentistry, efforts are being made to make operations more tolerable and less stressful for patients. For example, music and video goggles are employed to entertain and distract patients during the intervention. Newer approaches using video googles appear in more and more fields to reduce distress. Especially in vascular surgery and particularly in carotid surgery, the use of audiovisual distraction during the procedure has not been implemented to our knowledge, and its benefits remain undocumented. Because of the special setting and burden for the patients it is highly necessary to test these devices in carotid surgery and explore potential benefits for these patients.

It is currently unclear what activities aneurysms are involved in at the time of rupture. The aim of the study is to determine the activity performed at the time of aneurysm rupture.

The goal of this registry study is to optimize the results with intraocular lens implants used in cataract surgery.

Within the framework of the project presented here, a registry for traumatic vascular injuries will be established at Augsburg University Hospital. Patients who are treated at our hospital for an isolated vascular trauma or a vascular involvement in (poly-)trauma will be included. This is a rare complication of trauma, so data collection in a registry is useful to pool data on therapeutic procedures and outcome. These patients differ from the usual vascular surgery patient clientele because there is usually no previous vascular disease. Healthy vessels show different physiological responses than pre-diseased vessels. The usual therapeutic procedures and materials are also developed for arteriosclerotic or aneurysmatic vessels. Therefore, a core objective of this study is to assess long-term outcomes after vascular trauma.