Intact Fish Skin Graft to Treat Deep Diabetic Foot Ulcers.

BACKGROUND: Diabetic foot ulcers are chronic, difficult to heal, and potentially life-threatening. Few medical devices have been studied in diabetic ulcers penetrating to bone or tendon. METHODS: We conducted an international, open-label randomized controlled trial, randomly assigning patients with diabetic ulcers penetrating to bone, joint, or tendon 1:1 to intact fish skin graft or standard wound care, with assigned treatment applied through 14 weeks. The primary end point was the proportion of ulcers healed at 16 weeks, defined as reepithelization as identified by the investigator, and confirmed 14 days later. A blinded adjudication committee confirmed healing at both time points. Healing was also assessed at 20 and 24 weeks. RESULTS: Between July 2020 and November 2022, 255 patients were randomly assigned to intact fish skin graft (n=129) or standard of care (n=126). Healing was achieved in 44% of patients at 16 weeks with intact fish skin graft compared with 26% for standard of care (P<0.001, unadjusted), with additional healing at 20 weeks (46% vs. 32%) and 24 weeks (55% vs. 38%). Mean (SD) time to healing was 17.3 (0.69) weeks (95% confidence interval [CI], 15.5 to 18.7) for the intact fish skin graft group and 19.4 (0.66) weeks (95% CI, 18.1 to 20.7) for the standard of care group. In a Cox regression, intact fish skin graft was associated with faster time to healing (hazard ratio, 1.59; 95% CI, 1.07 to 2.36). Primary wound infections were the most common adverse event, occurring in 39 (30.2%) of patients in the intact fish skin graft group and 31 (24.6%) of patients in the standard of care group. CONCLUSIONS: Among patients with deep diabetic foot ulcers, treatment with intact fish skin graft was superior to standard of care in proportion of wounds healed at 16 weeks and was associated with faster time to healing. (Funded by European Commission Fast Track to Innovation Horizon 2020, and Kerecis Ltd. ClinicalTrials.gov NCT04257370.).

[Design of a clinical study to demonstrate the therapeutic benefit of another wound treatment product]. / Konzeption einer klinischen Studie zum Nachweis des therapeutischen Nutzens eines sonstigen Produktes zur Wundbehandlung.

BACKGROUND: Due to new legal requirements, a patient-relevant benefit for other wound treatment products (sPW) must be demonstrated through clinical studies if reimbursement at the expense of the statutory health insurance is sought in the non-inpatient sector. METHOD: An interdisciplinary group with expertise in clinical wound care has developed general recommendations for the design of suitable studies. In addition to regulatory documents, previous studies that have already been recognized as proof of benefit in other areas served as a basis. RESULTS: Randomized controlled trials that cover at least the most common types of chronic wounds (arterial, venous, diabetic or pressure sore) are recommended as the best method for gathering evidence. Despite the heterogeneous etiology of chronic wounds, the results should also be transferable to other wound types. The test intervention does not usually consist of the sPW alone, but of a combined wound treatment that follows a treatment plan that is as clearly defined as possible. In the comparison group, all wound treatment options (besides the sPW) must also be available and used according to a similar predefined treatment plan. Depending on the intended purpose and treatment goal, complete wound closure should, if possible, be recorded as the cardinal - although not always as the primary - endpoint. In justified cases, e.g. in the case of intermediate use as part of phase-appropriate wound therapy for chronic wounds, a significant reduction in the wound area can also be considered for benefit assessment. Quality of life (e.g. pain) can also justify a benefit and can therefore be recorded as a primary outcome parameter in clinical trials. The duration of the clinical trial should be adapted to the central endpoints, the medical or nursing goal of wound care and the intended purpose of the sPW. A benefit does not always arise from microbiological, physiological, laboratory or histological parameters or imaging findings.

Determining the Minimal Important Difference for the Wound-QoL Questionnaire.

BACKGROUND: The questionnaire for the quality of life with chronic wounds (Wound-QoL) is a valid and reliable instrument to determine the disease-specific health-related QoL of patients with chronic wounds. For the interpretation of HRQoL scores, it is additionally important to know which differences in scores are considered meaningful. The minimal important difference (MID) is defined as a change in HRQoL that a patient would consider meaningful, such that the patient would judge a treatment to be beneficial and worthy of repeating. OBJECTIVE: To interpret changes in the Wound-QoL scores and draw conclusions regarding the relevance of detected changes; the purpose of this study was to estimate the MID of the Wound-QoL global score and its subscales for patients with chronic wounds. PATIENTS AND METHODS: Patients completed the Wound-QoL before and four to six weeks after treatment and additionally gave a global rating of wound status change after treatment. The global rating of change served as an anchor question. MIDs were calculated based on an anchor-based and a distribution-based method. RESULTS: In total, 227 patients participated in the study. The mean age of the study population was 66.9 (± 12.7) median was 69.5, and 51.5% of the patients were female. MIDs for the Wound-QoL global score ranged from 0.47 to 0.52, proposing an overall estimation of 0.50. CONCLUSION: The results can be used to measure and interpret changes in wound-specific QoL over time.

Efficacy of antiseptic impregnation of aortic endografts with rifampicin compared to silver against in vitro contamination with four bacteria that frequently cause vascular graft infections.

OBJECTIVE: This in vitro study investigates the antimicrobial efficacy of impregnation of commercially available aortic endografts (EG) with rifampicin (RIF) and nanocolloidal silver. METHODS: Endografts were flushed with 50 mL of RIF 600 mg, 70 mL of a silver-based aqueous solution (AG), or 50 mL of phosphate-buffered saline (PBS) over 15 minutes. Endografts were then retrieved from the sheath and cut in 1 × 1 cm sized graft units (n = 80 of each impregnation), which were then incubated for 1 hour separately with inoculates containing 106 or 103 bacteria per milliliter (bact/mL) of each of the following bacteria: Staphylococcus epidermidis, Escherichia coli, multisensitive Staphylococcus aureus, and Pseudomonas aeruginosa. After sonication of the graft units, bacterial counts were measured by plating out twice the sonication solution on Mueller-Hinton plates. RESULTS: RIF showed a statistically significant decrease of colony forming units per milliliter for all four bacterial strains in both concentrations compared with PBS and AG, except for 103 bact/mL of E coli. AG showed a significant decrease of colony forming units per milliliter compared with PBS only for 106 bact/mL of E coli and was statistically significantly inferior to RIF for all four bacterial strains in both concentrations with the exception of E coli at a concentration of 103 bact/mL. CONCLUSIONS: This in vitro study demonstrated infectivity resistance of aortic EG after flushing with RIF. Moreover, the feasibility of flushing aortic EG with a new silver-based agent could be demonstrated, but without statistically significant antimicrobial efficacy compared with native EG.

Cervical Debranching in the Endovascular Era: A Single Centre Experience.

OBJECTIVE/BACKGROUND: Debranching of the supra-aortic arteries is a common practice either as part of a hybrid treatment of aortic arch pathology or owing to arterial occlusive disease. Results of the debranching techniques have not been reported frequently. METHODS: This was a retrospective single centre study of all consecutive patients with cervical debranching procedures as part of hybrid aortic arch repair. RESULTS: Between 2010 and 2017, 201 patients underwent 211 cervical debranching procedures in a tertiary centre. Mean ± SD patient age was 67.7 ± 10.7 years (70.6% males; n = 142/201) and mean ± SD body mass index (BMI) was 26.3 ± 5. In 78.7% of the cases carotid-subclavian bypass was performed alone (n = 166/211) followed by transposition of the subclavian artery to the ipsilateral carotid (n = 17/211; 8.1%) and in 28 cases (13.3%) a combination of procedures was performed. Twenty-four cases (11.4%) were complicated with local bleeding and 21 cases required re-intervention (10.4%). Nineteen patients (9.5%) developed local peripheral neurological damage post-operatively. Eight patients (3.8%) developed a chylous fistula and five (2.4%) presented with a local wound infection. One patient (0.5%) developed a bypass graft infection. The thirty day mortality was 7.6% (n = 16/211): one death occurred after isolated debranching without thoracic endovascular aneurysm repair (TEVAR; 0.5%). Whether the hybrid procedures were undertaken in a single stage (simultaneous TEVAR and cervical debranching) or two stage fashion appeared to have a significant impact on 30 day mortality (single stage n = 9/60 [15%] vs. debranching alone or two stage hybrid procedures n = 7/144 [4.9%]; p = .018). The major stroke incidence was 4.3% (n = 9/211); no strokes occurred after isolated debranching. Stroke was correlated with longer operating times (odds ratio [OR] 1.006; 95% confidence interval [CI] 1.000-1.011; p = .045) and higher BMI (OR 1.195; 95% CI 1.009-1.415; p = .039). Mean ± SD follow up was 15 ± 17 months (range 0-89 months). Primary cumulative graft patency during follow up was 98.1% (n = 207/211) and secondary patency was 100%. CONCLUSION: The results of cervical debranching procedures showed not only excellent patency rates, but also a significant rate of local complications. Carotid-subclavian bypass appeared to be safer with significantly fewer post-operative complications. Staged hybrid procedures also seemed to be safer.

Population Based Analysis of Gender Disparities in 23,715 Percutaneous Endovascular Revascularisations in the Metropolitan Area of Hamburg.

BACKGROUND: The worldwide prevalence of peripheral artery disease (PAD) is increasing and endovascular revascularisation (ER) has become the primary invasive treatment option. This study aims to illuminate gender disparities in ER of PAD. METHODS: This is a retrospective, cross sectional study design. All inpatient invasive, percutaneous endovascular treatments of PAD conducted in the metropolitan area of Hamburg (Germany) were collected consecutively between 01/2004 and 12/2015. Relevant socio-demographic risk factors, technical assessments, procedural details, and in hospital outcomes were collected and subsequently analysed. RESULTS: A total of 23,715 ERs were identified (39.7% females). Female patients were older (74 vs. 70 years, p < .001) and more often suffered from rest pain (12.0% vs. 9.7%, p < .001) at the time of presentation. No differences were found for index lesion complexity (Trans-Atlantic Inter-Society Consensus classes) and the ankle brachial index was less often stated not to be valid in females (5.9% vs. 7.1%, p = .005 for intermittent claudication; 28.5% vs. 32.0%, p = .001 for chronic limb threatening ischaemia, CLTI). If the ER was performed for CLTI, crural vessels below the knee were less often revascularised in females (32.2% vs. 42.7%, p < .001). Peri-operative major bleeding complications including pseudoaneurysms occurred twice as often in females, and female gender was an independent predictor of bleeding complications in the adjusted analyses (OR 2.32, 95% CI 1.49-3.64, p < .001 for IC; OR 1.67, 95% CI 1.10-2.53, p = .017 for CLTI). Lastly, females were more often transferred to nursing homes when compared with males (0.3% vs. 0%, p = .001 for IC; 2.5% vs. 1.2%, p < .001 for CLTI). CONCLUSION: In this study considering percutaneous ER for PAD, female patients were older, had different clinical symptoms, suffered more often from complications, and were at risk of social isolation after discharge when compared with their male counterparts. These results emphasise the need for further studies to evaluate a gender based treatment algorithm in PAD.

Multidisciplinary team decision is rare and decreasing in percutaneous vascular interventions despite positive impact on in-hospital outcomes.

Background: Worldwide prevalence of peripheral artery disease (PAD) is increasing and peripheral vascular intervention (PVI) has become the primary invasive treatment. There is evidence that multidisciplinary team decision-making (MTD) has an impact on in-hospital outcomes. This study aims to depict practice patterns and time changes regarding MTD of different medical specialties. Methods: This is a retrospective cross-sectional study design. 20,748 invasive, percutaneous PVI of PAD conducted in the metropolitan area of Hamburg (Germany) were consecutively collected between January 2004 and December 2014. Results: MTD prior to PVI was associated with lower odds of early unsuccessful termination of the procedures (Odds Ratio 0.662, p < 0.001). The proportion of MTD decreased over the study period (30.9 % until 2009 vs. 16.6 % from 2010, p < 0.001) while rates of critical limb-threatening ischemia (34.5 % vs. 42.1 %), patients´ age (70 vs. 72 years), PVI below-the-knee (BTK) (13.2 % vs. 22.4 %), and rates of severe TASC C/D lesions BTK (43.2 % vs. 54.2 %) increased (all p < 0.001). Utilization of MTD was different between medical specialties with lowest frequency in procedures performed by internists when compared to other medical specialties (7.1 % vs. 25.7 %, p < 0.001). Conclusions: MTD prior to PVI is associated with technical success of the procedure. Nonetheless, rates of MTD prior to PVI are decreasing during the study period. Future studies should address the impact of multidisciplinary vascular teams on long-term outcomes.

Post-operative Infection of Prosthetic Materials or Stents Involving the Supra-aortic Trunks: A Comprehensive Review.

OBJECTIVE: The aim of this paper was to provide recommendations for diagnosis and management in the setting of infection following open or endovascular reconstructions of the supra-aortic trunks. METHODS: A review of the Medline database was performed from 1997 to 2017 by a combined strategy of MeSh terms. RESULTS: The literature search identified 49 publications: 36 studies addressing prosthetic material infections and 13 studies addressing stent infections. A total of 140 cases of prosthetic material infections were reported, mostly involving carotid patches. Surgical treatment was mostly based on complete removal of the infected material followed by in situ arterial reconstruction (86 cases, 62.3%). Peri-operative complications included cranial nerve injury in 17 cases (12.5%), stroke in eight (6.7%), bleeding in four (2.9%), re-infection in five (3.6%), and cardiac failure in three cases (2.2%). Stent infections were reported in 12 patients: eight carotid stents, three subclavian stents and one tandem brachiocephalic subclavian stent. Treatment was not described for one case, was conservative in one case, consisted of stent removal with venous reconstruction in six cases, stent removal without reconstruction because of carotid thrombosis in two cases, and carotid embolisation in two cases. Complications included intra-operative death in one case (9.1%), stroke in two (18.2%), reinfection in one (9.1%), bleeding in one (9.1%), and cardiac failure in one case (9.1%). CONCLUSION: Appropriate pre-operative imaging is mandatory and treatment modality should be determined by patient condition. Complete removal of the infected material, followed by in situ arterial reconstruction with venous material seems advisable, despite high morbidity. However, alternative strategies may be considered for fragile and high risk patients. A multidisciplinary approach is mandatory to ensure optimum results.

Renal Function Salvage After Delayed Endovascular Revascularization of Acute Renal Artery Occlusion in Patients With Fenestrated-Branched Endovascular Aneurysm Repair or Visceral Debranching.

PURPOSE: To analyze the renal function and outcome after delayed (>6 hours) endovascular revascularization of acute renal artery occlusion (RAO) in patients with fenestrated-branched endovascular aneurysm repairs (EVARs) or open visceral debranching. METHODS: A single-center retrospective analysis was conducted involving 7 patients (mean age 61 years, range 49-72; 5 women) with 9 RAOs treated with endovascular revascularization between December 2014 and March 2017. Three patients had a solitary kidney with chronic renal insufficiency; 1 patient had bilateral occlusions as the acute event. Initial aortic surgery included 5 branched and 1 fenestrated EVAR as well as 1 open visceral debranching operation. Revascularization of the RAO was performed using aspiration thrombectomy, local lysis therapy, and stent-graft relining. The median time between initial aortic surgery and RAO was 10 months (range 0.5-17). RESULTS: Median renal ischemic time to revascularization was 24 hours (range 7-168). Technical success was 100%, with 1 procedure-related access complication. Temporary dialysis dependency occurred in 4 patients. Mean in-hospital stay was 17 days (range 7-32) with 1 postoperative death at day 10 due to cardiac arrest of unknown cause. Mean follow-up was 10.3 months (range 1.5-27) in 5 of 6 discharged patients. During follow-up, 1 reintervention for recurrent occlusion was performed. At follow-up imaging, all renal arteries were patent. No permanent dialysis dependency occurred. CONCLUSION: Renal function can be salvaged by delayed revascularization for RAO with prolonged renal ischemia. The endovascular approach with aspiration thrombectomy, local lysis, and stent-graft relining is a feasible technique for revascularization after RAO in patients with fenestrated-branched EVAR or open visceral debranching.

Contemporary concepts in hernia prevention: Selected proceedings from the 2017 International Symposium on Prevention of Incisional Hernias.

Incisional hernia is a frequent complication of midline laparotomy and enterostomal creation and is associated with high morbidity, decreased quality of life, and high costs. The International Symposium on Incisional Hernia Prevention was held October 19-20, 2017, at the InterContinental Hotel in San Francisco, CA, hosted by the Department of Surgery, University of California, San Francisco. One hundred and three attendees included general and plastic surgeons from 9 countries, including principal participants for several of the seminal studies in the field. Over the course of the 2-day meeting, there were 38 oral presentations, 3 keynote lectures, and 2 panel discussions. The Symposium was a combination of new information but also a comprehensive review of the existing data so as to assess the current state of the field and to set the stage for future research. Further, the Symposium sought to increase awareness and thus emphasize the importance of preventing the formation of incisional and enterostomal hernias.

Health-related quality of life and patient burden in patients with split-thickness skin graft donor site wounds.

Split-thickness skin grafting is a common procedure to treat different kinds of wounds. This systematic, multicentre, observational, cross-sectional study of adult patients with split-thickness skin graft (STSG) donor site wounds was conducted to evaluate quality of life (QoL) impairments caused by donor site wounds following split-thickness skin grafting. Therefore, 112 patients from 12 wound centres in Germany were examined based on patient and physician questionnaires as well as a physical examination of the donor site wound. Most indications for skin grafting were postsurgical treatment (n = 51; 42.5%) and chronic wounds (n = 47; 39.2%). European QoL visual analoque scale (EQ VAS) averaged 64.7 ± 23.3, European QoL 5 dimensions (EQ-5D) averaged 77.4 ± 30.0. Wound-QoL (range: 0-4) was rated 0.8 ± 0.8 post-surgery and 0.4 ± 0.6 at the time of survey (on average 21 weeks between the time points). Compared to averaged Wound-QoL scores of chronic wounds donor site-related QoL impairments in split-thickness skin-graft patients were less pronounced. There were significant differences in patient burden immediately after surgery compared to the time of the survey, with medium effect sizes. This supports the hypothesis that faster healing of the donor site wound leads to more favourable patient-reported outcomes.

["Surgeon-modified" Stent Grafts in Emergency Cases as Addition to Off-the-shelf Stent Grafts for Complex Abdominal and Thoracoabdominal Aortic Pathologies]. / "Surgeon-modified" Stentgrafts für den Notfall ­ Ergänzung zu "off-the-shelf" Prothesen für die Versorgung von komplexen abdominellen und thorakoabdominellen Aortenpathologien.

Background Endovascular techniques have revolutionised the therapy of abdominal and thoracoabdominal aortic disease. For infrarenal abdominal aortic aneurysm, the endovascular aortic repair has become a standard for elective and emergent cases. In complex abdominal or thoracoabdominal aortic pathologies, involving reno-visceral vessels, there are technical challenges for open and endovascular surgery. Due to high mortality and morbidity of open surgery of complex aortic lesions, especially in emergent cases, endovascular techniques have developed as well. Results Endovascular treatment options for complex aortic pathologies are fenestrated and branched stent grafts and the chimney graft technique. In elective cases, fenestrated and branched stent grafts are ordered as "custom-made" devices but planning, production and delivery takes up to approximately 12 weeks. For urgent cases, there recently only exists one 4-vessel branched "off-the-shelf" stent graft, that fits only about 60% of patients' anatomy in complex abdominal or thoracoabdominal aneurysm cases. As an alternative for these patients, "surgeon-modified" stent grafts are a treatment option. Here, a commercially available stent graft is modified with the needed fenestrations and branches for the visceral vessel prior to the operation. Compared to off-the-shelf stent grafts, the surgeon-modified stent grafts have similar results for mortality and morbidity. Conclusion As long as off-the-shelf devices for a larger variety of abdominal and thoracoabdominal anatomy are available, surgeon-modified stent grafts are a good treatment alternative for urgent complex abdominal and thoracoabdominal aortic pathologies in high-risk patients.

Validity and feasibility of the wound-QoL questionnaire on health-related quality of life in chronic wounds.

Chronic wounds have a major socioeconomic impact due to their frequency, chronicity, and societal costs. Patients experience substantial quality of life (QoL) impairments. The use of questionnaires for a continuous assessment of QoL and resulting interventions to improve the situation of the individual are an important cornerstone of a guideline-based wound care. The aim of this study was to investigate the validity of the Wound-QoL questionnaire. Patients with chronic wounds from two different centers were included in the prospective study. All patients completed the Wound-QoL and two other QoL questionnaires (European Quality of Life-5 Dimensions, EQ-5D, and Freiburg Life Quality Assessment for wounds, FLQA-wk) at baseline and at two more time points (4 and 8 weeks, respectively). Wound status was defined with an anchor question. Two hundred and twenty-seven patients (48.5% women) participated in the study. Mean age was 66.9 years (range 17-96, median 69.5). Indications were venous leg ulcers (40.1%), pyoderma gangraenosum (14.1%), diabetic or ischemic foot ulcers (5.3%), pressure ulcers (2.6%), and other etiologies (30.0%). The Wound-QoL showed good internal consistency, with high Cronbach's alpha in all the subscales and in the global scale in all time points (>0.8). Convergent validity was satisfactory since there were significantly (p ≤ 0.001) good correlations with the EQ-5D (range = 0.5-0.7) and FLQA-wk global score (r > 0.8) at every time point. Responsiveness was high, too. The Wound-QoL is a simple, valid tool for the longitudinal assessment of QoL in patients with chronic wounds. This questionnaire is suitable for use in clinical trials, quality of care studies and clinical routine.

Outcome of Surgeon-Modified Fenestrated/Branched Stent-Grafts for Symptomatic Complex Aortic Pathologies or Contained Rupture.

PURPOSE: To analyze the outcome of surgeon-modified fenestrated and branched stent-grafts (sm-FBSG) in high-risk patients with symptomatic complex aortic pathology or contained rupture. METHODS: A single-center retrospective analysis was conducted of 21 consecutive patients (mean age 70 years, range 58-87; 16 men) treated with a sm-FBSG from April 2014 to September 2016. The indications included 11 thoracoabdominal and 10 pararenal aortic pathologies, which presented as symptomatic in 8 and as contained rupture in 13 patients. The mean aneurysm diameter was 7.4±2.3 cm. RESULTS: Technical success was 100%. From 1 to 4 (mean 3) renovisceral branch vessels were targeted with fenestrations. The mean length of in-hospital stay was 19 days (range 1-78). There was 1 death within 30 days and 2 further in-hospital deaths. Two patients suffered permanent spinal cord injury, 2 developed respiratory failure, and 2 had renal failure requiring temporary or permanent dialysis. No myocardial infarction, stroke, or bowel ischemia occurred. Six early endoleaks (3 type II and 3 minor type III) were detected. Mean follow-up was 11.2 months (range 2-33) in 17 patients. One late aneurysm-related death occurred. All 13 follow-up imaging studies showed patent target renovisceral vessels, with 1 type I and 2 type II endoleaks. CONCLUSION: Sm-FBSG can be utilized for urgent treatment of complex abdominal and thoracoabdominal aortic pathologies in high-risk patients with anatomy unsuitable for commercially available stent-grafts.

Reversed Frozen Elephant Trunk Technique to Treat a Type II Thoracoabdominal Aortic Aneurysm.

PURPOSE: To describe a hybrid technique of reversed frozen elephant trunk to treat thoracoabdominal aortic aneurysms (TAAA) through an abdominal only approach. TECHNIQUE: The technique is demonstrated in a 29-year-old Marfan patient with a chronic type B aortic dissection previously treated with a thoracic stent-graft who presented with a thoracoabdominal false lumen aneurysm. Through an open distal retroperitoneal approach to the abdominal aorta, a frozen elephant trunk graft was implanted over a super-stiff wire upside down with the stent-graft component in the thoracic aorta. Following deployment of the stent-graft proximally and preservation of renovisceral perfusion in a retrograde manner, the renovisceral vessels were sequentially anastomosed to the elephant trunk graft branches, thus reducing the ischemia time of the end organs. The aortic sac was then opened, and the distal part of the hybrid graft was anastomosed with a further bifurcated graft to the iliac vessels. CONCLUSION: The reversed frozen elephant trunk technique is feasible for hybrid treatment of TAAAs via an abdominal approach only. This has the benefit of substantially reducing the trauma of thoracic exposure, thus preserving major benefits of open thoracoabdominal surgery, such as the presence of short bypasses to the renovisceral vessels and reimplantation of lumbar arteries to reduce spinal cord ischemia.