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.

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.

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.

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.

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.

Sutureless fixation with fibrin glue of lightweight mesh in open inguinal hernia repair: effect on postoperative pain: a double-blind, randomized trial versus standard heavyweight mesh.

BACKGROUND: Open inguinal hernia repair is associated with a low incidence of complications that can be influenced by the type of mesh and its method of fixation. Our aim was to investigate the frequency and severity of postoperative pain and other complications when lightweight, large-pore meshes, compared with heavyweight, small-pore meshes, are fixed with human fibrin glue (HFG) during open inguinal hernia repair. METHODS: A cohort of 80 patients undergoing open inguinal repair were enrolled. Forty patients received a lightweight and large porous mesh and 40 a standard heavyweight mesh with small pores. In all patients, HFG was used for mesh fixation. RESULTS: Patients who received lightweight, large-pore mesh reported less pain than those in the control group both postoperatively (2.8 ± 1.1 vs. 4.9 ± 1.1; P = .0003) and at 1-month follow-up (1.7 ± 1.0 vs. 3.1 ± 1.0; P = .0038), and took fewer analgesics. There was no difference in days off work/activity. No differences were observed concerning postoperative complications. After 6 months there was no difference in groin pain between groups. CONCLUSION: Patients who underwent open inguinal hernia repair with lightweight, large-pore mesh fixed with HFG experienced less pain throughout the first month after operation compared with those receiving standard mesh.