When amputation is not the end of the challenge: A successful therapy for osteomyelitis and soft tissue infection in a patient with type 1 diabetes.

Infection is a common complication in patients with diabetic foot ulcer, leading to lower extremities amputation and healing failure. In this article, we report the case of a 39-year-old man with diabetes who developed a severe soft tissue infection and osteomyelitis after experiencing a major amputation for wet gangrene of both the foot and the ankle.

Hard-to-heal wound treated with Integra Flowable Wound Matrix: analysis and clinical observations.

Skin healing defects severely impair the quality of life of millions of people and burden healthcare systems globally. The therapeutic approach to these pathologies still represents a challenge. Novel scaffolds, used as dermal substitutes, possibly represent a promising strategy in complex wound management. Integra Flowable Wound Matrix (IFWM) is composed of a lyophilised, micronised form of collagen/chondroitin sulphate matrix, already used in regenerative medicine and endorsed in the therapy of diabetic foot lesions. In this paper, IFWM was applied to a tunnelling hard-to-heal skin lesion in order to restore tissue integrity. Although the different phases of skin wound healing are well established, the molecular mechanism underpinning IFWM-induced tissue repair are almost unknown. Here, we report, for the first time, the comparative analysis of molecular, histological and clinical observations of the healing process of a hard-to-heal tunnelling skin wound. The therapeutic success of this clinical case allowed us to recommend the use of IFWM as a tissue substitute in this rare type of hard-to-heal wound in which the high inflammatory status hampered the natural healing process.

Acellular Dermal Matrix Used in Diabetic Foot Ulcers: Clinical Outcomes Supported by Biochemical and Histological Analyses.

Diabetic foot ulcer (DFU) is a diabetes complication which greatly impacts the patient's quality of life, often leading to amputation of the affected limb unless there is a timely and adequate management of the patient. DFUs have a high economic impact for the national health system. Data have indeed shown that DFUs are a major cause of hospitalization for patients with diabetes. Based on that, DFUs represent a very important challenge for the national health system. Especially in developed countries diabetic patients are increasing at a very high rate and as expected, also the incidence of DFUs is increasing due to longevity of diabetic patients in the western population. Herein, the surgical approach focused on the targeted use of the acellular dermal matrix has been integrated with biochemical and morphological/histological analyses to obtain evidence-based information on the mechanisms underlying tissue regeneration. In this research report, the clinical results indicated decreased postoperative wound infection levels and a short healing time, with a sound regeneration of tissues. Here we demonstrate that the key biomarkers of wound healing process are activated at gene expression level and also synthesis of collagen I, collagen III and elastin is prompted and modulated within the 28-day period of observation. These analyses were run on five patients treated with Integra® sheet and five treated with the injectable matrix Integra® Flowable, for cavitary lesions. In fact, clinical evaluation of improved healing was, for the first time, supported by biochemical and histological analyses. For these reasons, the present work opens a new scenario in DFUs treatment and follow-up, laying the foundation for a tailored protocol towards complete healing in severe pathological conditions.

Antibiotic resistance in diabetic foot infection: how it changed with COVID-19 pandemic in a tertiary care center.

AIM: To investigate the rate of antibiotic resistance and its main risk factors in a population of patients with diabetic foot infection (DFI) during the COVID-19 pandemic, in comparison with the population of 2019. METHODS: Two hundred and twenty-five patients with DFI were admitted in a tertiary care center from January 2019 to December 2020. Antibiotic resistance was evaluated by microbiological examination of soft tissues' or bone's biopsy. RESULTS: Compared with 2019 group (n = 105), 2020 group (n = 120) had a significantly higher prevalence of antibiotic resistance [2019 vs 2020, 36% vs 63%, P <0.001] and more often was admitted with recent or current antibiotic therapy (18% vs 52%, P <0.001), which was frequently self-administered (5% vs 30%, P = 0.032). The risk of antibiotic resistance was also higher in 2020 group [OR 95% CI, 2.90 (1.68 to 4.99)]. Prior hospitalization, antibiotic self-administration and antibiotic prescription by general practitioners resulted as independent predictors of antibiotic resistance. CONCLUSIONS: In a population of people with DFI admitted in a tertiary care center during the COVID-19 pandemic the prevalence of antibiotic resistance was higher than 2019. Previous hospitalization, antibiotic self-administration /prescription by general practitioners were related to higher risk of antibiotic resistant infections.

Expanded negative pressure wound therapy in healing diabetic foot ulcers: a prospective randomised study.

OBJECTIVE: This study aims to evaluate the benefits of treating diabetic foot ulcers (DFU) through a revised procedure using the mechanisms underlying negative pressure wound therapy (NPWT) in such a way as to achieve reduced and more evenly distributed lateral tension lines across the wound. METHOD: Patients with type 2 diabetes were assessed for elegibility. Included patients were divided randomly into two groups: the NPWT control group and the NPWT+ group. Patients in the NPWT control group were treated in the traditional manner: wounds were covered with foams shaped to fit the wound precisely. In the NPWT+ group, foams were shaped to fit the wound precisely, and an additional foam was then wrapped around the foot. RESULTS: Some 85 patients were assessed for eligibility; 59 were randomised into two groups: 29 patients in the NPWT+ group and 30 patients in the NPWT group. The primary objective was median healing time (NPWT+ 19 days, interquartile ratio (IQR) 7.5; NPWT 33 days, IQR 16; p<0.00001), and complete wound healing at three weeks (NPWT+ 55.20% NPWT 26.70% p=0.02). Secondary endpoints included number of major amputations (none in either group) and number of infections (NPWT+ 3.44% of patients, NPWT 6.66% of patients; p=0.57). CONCLUSION: Our initial findings show that this treatment significantly reduced wound closure times and accelerated healing in DFUs. It also demonstrated promising improvements in healing rates, with no significant increase in wound complications.

Acellular Flowable Matrix in the Treatment of Tunneled or Cavity Ulcers in Diabetic Feet: A Preliminary Report.

OBJECTIVE: The authors aimed to explore the feasibility and safety of an advanced, acellular, flowable wound matrix (FWM) in patients with diabetes-related cavity or tunnel lesions involving deep structures. METHODS: Patients with diabetic foot ulcers were hospitalized at the General and Geriatric Surgery Unit of the University of Campania in Naples, Italy, between March 2015 and December 2015. Twenty-three patients with tunneled or cavity ulcers were treated. The lesions were filled with the FWM. Surgical wound edges were either approximated with stitches or left to heal by secondary intention. MAIN RESULTS: After 6 weeks, 78.26% of patients completely healed after a single application of the FWM. The healing time for all healed wounds was 30.85 ± 12.62 days, or 26.11 ± 5.43 days in patients for whom wound edges were approximated by stitches, and 57.66 ± 3.05 days in the patients who healed by secondary intention (P = .01). Permanent tissue regeneration was observed in a high percentage of patients, and shorter healing time was achieved. Study authors observed a low rate of complications such as major amputation and increased hospitalization. CONCLUSIONS: The FWM seems ideal for tunneled and cavity ulcers with irregular geometry. This new porous matrix allows closure of the lesion while reducing healing time and demolition surgery.

An evaluation of an ultrasonic debridement system in patients with diabetic foot ulcers: a case series.

OBJECTIVE: This study evaluated the use of ultrasonic debridement in patients with diabetic foot ulcers (DFU). METHOD: In this prospective, single-arm, open-label study, all patients with DFUs underwent wound debridement by ultrasonic debridement system (SonicOne OR Ultrasonic debridement system). Wherever possible, the edges were approximated by means of stitches. In other cases, the surgical breach healed by secondary intention, or a partial thickness skin graft (with or without Integra Dermal Regeneration Template or Integra Flowable Wound Matrix) was applied, and subsequently healed by primary intention. RESULTS: We assessed 15 patients with a DFU. The time required for debridement was short (an average 15.06±4.02 minutes). Complete wound healing (defined as 100% re-epithelialisation) was achieved in all 15 cases. Median time to heal was 39.20±16.05 days. The ultrasonic debridement system was found to show adequate debridement while preserving more viable tissue to promote rapid healing. CONCLUSION: Our findings show that the device demonstrates advantages in the reduction of debridement times, and efficacy in safely preserving the viable tissue, with a low complication rate in surgery of DFUs. A study that uses a larger cohort is required to fully evaluate the effectiveness, or otherwise, of the ultrasonic debridement system.

Efficacy of a New Flowable Wound Matrix in Tunneled and Cavity Ulcers: A Preliminary Report.

INTRODUCTION: In chronic wounds the healing is stagnant, and regenerative surgery is often needed. Many engineered tissues with a conventional bidimensional sheet are ineffective for tunneling wounds, because adherence to the wound bed is not complete. An advanced wound matrix for treating wounds with irregular geometries has been developed (Integra Flowable Wound Matrix, Integra LifeScience Corp, Plainsboro, NJ). METHODS AND MATERIALS: Between March 2013 and December 2013 the authors treated 18 patients (11 female) with tunneled or cavity ulcers with the advanced wound matrix at the Unit of General and Geriatric Surgery of the Second University of Naples, Naples, Italy. Two patients (11.1%) had postsurgical wounds, two (11.1%) had post-traumatic wounds, and 14 (77.8%) had neuropathic ulcers. After debridement and antibiotic therapy, the lesions were filled with the wound matrix product. Surgical wound edges were either approximated with stitches or left to heal by secondary intention and covered with wet gauze. During the first week, follow-up visits were carried out every 3 days, then once a week until complete healing was achieved. All patients underwent preoperative and postoperative ultrasonography scans and plain radiograph controls. RESULTS: Twenty-one applications were performed. Engraftment was complete in all but 1 patient who had diabetes and graft failure. Three patients needed repeated applications to complete the filling of the lesions. Median (range) pain Visual Analog Scores-on a scale of 0 to 10, where 0 = no pain, and 10 = intolerable pain-were 6.3 (range 3-8) preoperatively and 0.5 (range 0-2) at first follow-up (P ≤ 0.001). All but 2 patients showed a progressive remodeling of the tissue gap at scheduled radiographic controls. CONCLUSIONS: To the author's knowledge, the advanced wound matrix used in this study is the only available biomaterial for the treatment of tunneled lesions. It stimulates tissue regeneration by filling surfaces which cannot be repaired spontaneously or by using conventional biomaterials in the form of sheets. Its application is atraumatic, painless, and safe.

Preventive NPWT over closed incisions in general surgery: does age matter?

Surgical site events (SSE), including surgical wound complications and surgical site infections, are a major concern in patients undergoing general surgery operations. These increase the costs of care, and can lead to prolonged hospital stay and need for further treatments, ultimately resulting in poor quality of life. Negative pressure wound therapy (NPWT) has been recently reported as a preventive strategy to avoid SSE, but little is known on the topic, and particularly in geriatric population. Our primary aim was to assess the efficacy of NPWT by means of a pocket device (PICO, Smith & Nephew, London, UK) in preventing SSE compared with conventional dressings in patients undergoing surgery with primary wound closure for breast and for colorectal diseases in our Unit. Our secondary aims were to assess the efficacy and safety of PICO in elderly patients, and to seek for differences between breast and abdominal results. All consecutive patients undergoing breast and colorectal surgery in our Unit between September 2012 and May 2014 were prospectively enrolled in this open label controlled study. Breast patients receiving NPWT were assigned to group B1, those receiving conventional dressings were assigned to group B2. Colorectal patients were assigned to group C1 (NPWT) and C2 (conventional dressings) in similar fashion. Each group included 25 patients, and at least 10 (40%) patients aged over 65 years to allow sub-analyses. NPWT significantly reduced SSE in both breast and colorectal patients compared with controls. No significant differences were observed according to age. Similar benefits were observed in breast and colorectal patients. Our results suggest that PICO is an effective tool to prevent SSE in patients undergoing general surgery, irrespective of age. Its use is recommended in frail, elderly patients at risk of SSE.

New advances in negative pressure wound therapy (NPWT) for surgical wounds of patients affected with Crohn's disease.

Surgical site complications (SSC) negatively affect costs of care and prolong length of stay. Crohn's disease (CD) is a risk factor for SSC. CD patients often need surgery, sometimes requiring stoma. Our primary aim was to compare the effects on SSC of a portable device for NPWT (PICO, Smith & Nephew, London, UK) with gauze dressings after elective surgery for CD. Secondary aims were manageability and safety of PICO and its feasibility as home therapy. Between 2010 and 2012, 50 patients were assigned to treatment with either PICO (n = 25) or conventional dressings (n = 25). Each patient completed 12-month follow-up. Parameters of interests for primary aim were SSC, surgical complications, and readmission rates. Data on difficulties in managing PICO and device-related complications were also collected. Patients receiving PICO had less SSC, resulting in shorter hospital stay. At last follow-up, readmission rates were lower with PICO. No differences were observed in surgical complications between groups. No patients reported difficulties in managing the device. Among patients discharged with PICO, none needed to come back to the hospital for device malfunctioning or inability to manage it. PICO reduces SSC and length of stay in selected CD patients compared with conventional dressings. The device is safe and user friendly.

Effects of a new pocket device for negative pressure wound therapy on surgical wounds of patients affected with Crohn's disease: a pilot trial.

INTRODUCTION: Surgical site infections (SSIs) affect costs of care and prolong length of stay. Crohn's disease (CD) represents an independent risk factor for SSI. The risk can be further increased by concomitant administration of immunosuppressive drugs and poor performance status at the time of surgery. Patients suffering from CD often need more than one surgical intervention during life, sometimes requiring fashioning of a stoma. The aim of this pilot study was to compare a portable device for negative pressure wound therapy (PICO, Smith & Nephew, London, UK) to conventional gauze dressings in patients undergoing surgery for stricturing CD. METHODS: Between January 2010 and November 2011, this controlled trial enrolled 30 patients, who were assigned to treatment with either PICO (n = 13) or conventional dressings (n = 17). Each patient completed a 3-month follow-up. RESULTS: Patients receiving PICO experienced significantly less postoperative wound complications (P = .001) and SSI (P = .017) compared with those who received conventional dressings. This resulted in shorter hospital stay (P = .0007). No significant differences in cosmetic results were found. CONCLUSION: These data suggest that PICO allows faster and safe discharge by reducing the incidence of SSI and wound-related complications in selected patients undergoing surgical intervention for stricturing CD. This could be particularly useful in patients receiving steroids.

Dipeptidyl peptidase 4 inhibition may facilitate healing of chronic foot ulcers in patients with type 2 diabetes.

The pathophysiology of chronic diabetic ulcers is complex and still incompletely understood, both micro- and macroangiopathy strongly contribute to the development and delayed healing of diabetic wounds, through an impaired tissue feeding and response to ischemia. With adequate treatment, some ulcers may last only weeks; however, many ulcers are difficult to treat and may last months, in certain cases years; 19-35% of ulcers are reported as nonhealing. As no efficient therapy is available, it is a high priority to develop new strategies for treatment of this devastating complication. Because experimental and pathological studies suggest that incretin hormone glucagon-like peptide-1 may improves VEGF generation and promote the upregulation of HIF-1α through a reduction of oxidative stress, the study evaluated the effect of the augmentation of GLP-1, by inhibitors of the dipeptidyl peptidase-4, such as vildagliptin, on angiogenesis process and wound healing in diabetic chronic ulcers. Although elucidation of the pathophysiologic importance of these aspects awaits further confirmations, the present study evidences an additional aspect of how DPP-4 inhibition might contribute to improved ulcer outcome.

Our experience of total mesorectal excision for rectal cancers.

BACKGROUND/AIMS: The total mesorectal excision (TME) for rectal tumours was introduced in 1982 by Heald et al. and has led both to a 5% de crease of local recurrences 5 and 10 years after the operation when compared with cases treated with conventional surgery, and to an increase of survival up to five years estimated in 80% of all cases. In Italy TME was firstly introduced for distal rectal carcinomas about 20 years ago, and has shown the same rate of local recurrences reported by Heald. The aim of our work is to highlight TME advantages and demonstrate how this more demanding and longer lasting method has an acceptable risk for the surgery of rectal tumours. METHODOLOGY: We have compared two groups of patients operated for rectal carcinoma; the first, "historical control group" (no TME, including 46 patients) was treated with the standard surgery technique, while the second group (TME, 47 patients) underwent the total mesorectal excision technique. 14 of non TME patients belonged to Dukes stage A, 20 to stage B and 12 to C; whereas in the TME group 16 patients belonged to Dukes stage A, 23 to B and 8 to C. The patients of both groups undergone the exams of follow up (blood test, hepatic ultrasonography, abdominal CT, thorax Ro); the follow up pattern included periodic controls with a check-up every three and six months, from one to five years. RESULTS: Postoperative complications in both groups do not show important differences in rates, although, the first group (no TME) had 11 cases with postoperative complications confronted with the 8 cases of the second group (TME). The complications taken into consideration were: anastomotic bleeding (3 patients no TME, 6% vs 1 patients TME, 2%), intestinal obstruction (1 patient no TME, 2% vs 1 patient TME, 2%), parietal infection (4 patients no TME, 9% vs 3 patients TME, 6%), anastomotic fistulae (2 patients no TME, 4% vs 2 patients TME, 4%), retention of urine and vesicular disorder (1 patient no TME, 2% vs 1 patient TME, 2%). Tumours closer to the anus have shown more complications compared with tumours at higher levels. As a matter of fact, 9 cases of no TME and TME patients with low located tumours have undergone complications compared with the 3 cases of no TME and TME patients with tumours being more distant from the anus; the rest 7 cases belonged to the middle rectum. A higher rate of local recurrences was noticed in the no TME group: 6 (13%) compared with the TME group: 3 (6%). Other tardy complications taken into consideration were: hepatic metastasis (5 patients no TME, 11% vs 4 patients TME, 8%), pulmonary metastasis (3, 6% of the no TME vs 2, 4% of the TME), anastomotic stenosis (4, 9% of the no TME vs 2, 4% of the TME), impotence (2, 4% of the no TME vs 1, 2% of the TME). We also noticed that most of the tardy complications in the TME group belonged to Dukes stage C. CONCLUSION: From our experience, we concluded that, in TME patients, complications are lower than in no TME patients; the site of the tumour affects the appearance of complications which are more frequently in distal localizations. An important result is the minor incidence of local recurrences after TME, which brings us to the conclusion that TME can be considered a valid method with an acceptable risk for the surgery of rectal tumour.

The use of a dermal substitute and thin skin grafts in the cure of "complex" leg ulcers.

BACKGROUND: In some chronic leg ulcers, a reconstructive operation using skin grafts may be extremely difficult or is quite likely to fail as a result of the position, the width, and the depth of the lesions. OBJECTIVE: To evaluate the effectiveness of a dermal substitute and thin skin grafts in the treatment of patients suffering from deep and wide chronic leg ulcers. MATERIALS & METHODS: Twenty-six consecutive patients with leg ulcers at least 1 year old were admitted to the study. The ulcers were large (>100 cm2) and deep (>3 mm) over at least 50% of the surface area. After surgical debridement of the wounds, the dermal matrix was modeled and applied. After 21 days, the attachment of the artificial dermis was tested, and in positive cases, the patient was re-admitted for "thin" skin grafting. RESULTS: In all patients, at the first follow-up, a notable reduction in pain, exudate, and perilesional edema was ascertained. After 2 weeks, the progressive substitution of granulation tissue with new yellow or gold derma became evident in all patients. After 21 days, the dermal matrix was completely integrated with the guest tissue. In 23 patients (88.5%), attachment of the skin graft was complete, and in three patients (11.5%), it was partial but nevertheless larger than 70% of the surface. Even in these cases, complete healing of the lesions was achieved within 4 weeks at most. All patients were checked for a minimum of 3 months, and none suffered an ulcerous recurrence. CONCLUSION: In our series, the use of this dermal matrix allowed for the complete refilling of the loss of tissue, the rapid disappearance of pain, and the rapid regeneration of a permanent dermis.

[Day care varicose vein surgery in elderly patients. 10 years of experience]. / Il trattamento della malattia varicosa del paziente anziano in regime di Day Surgery. Dieci anni di esperienza.

At present the surgical treatment of lower limb varicose veins is performed mainly as day case surgery. Since 30% of elderly people suffer from this disease, the feasibility of phlebological operations in elderly patients in a day care setting is an emerging problem. All patients (2032 patients) who underwent varicose vein surgery in our Geriatric Surgery Department over a 10-year period from January 1993 to December 2002 were evaluated retrospectively; 312 patients (15.35%) were aged above sixty-five years. In this group of elderly patients, 214 (68.6%) were operated on as inpatients and 98 (31.4%) as day care cases; in the younger group, 60.23% were treated in a day care regimen. All patients were examined and selected depending on general conditions, local conditions and logistics. Among the general conditions the exclusion criteria for elderly patients were concomitant diseases (43.9%) and anxiety (17.8%); as a consequence of local conditions, 31 patients (14.5%) with extensive bilateral varices and 27 patients (12.6%) with complicated recurrent disease were excluded from day care surgery; 24 patients (11.2%) were excluded because of logistics. Almost half (44.9%) of the elderly patients required multiple admissions for diagnostic investigations. The elderly patients underwent fewer saphenous strippings (7.1% vs 15.9%) and below-knee strippings (48.0% vs 56.9%); on the other hand, there were more operations on perforating veins (7.1% vs 1.4%), more varicectomies 10.2% vs 1.7%) and more skin grafts for ulcers (8.2% vs 2.2%). No problems occurred during the interventions and none of the patients had to be re-admitted to hospital for complications. This study provides evidence that varicose veins can be safely managed in a day care unit even in elderly patients, though careful preoperative selection is necessary.