Endoscopic vacuum therapy significantly improves clinical outcomes of anastomotic leakages after 2-stage, 3-stage, and transhiatal esophagectomies.

BACKGROUND: Anastomotic leakages after esophagectomies continue to constitute significant morbidity and mortality. Intrathoracic anastomoses pose a high risk for mediastinitis, sepsis, and death, if a leak is not addressed timely and appropriately. However, there are no standardized treatment recommendations or algorithms as for how to treat these leakages. METHODS: The study included all patients at the University Hospital Regensburg, who developed an anastomotic leakage after esophagectomy with gastric pull-up reconstruction from 2007 to 2022. Patients receiving conventional treatment options for an anastomotic leakage (stents, drainage tubes, clips, etc.) were compared to patients receiving endoscopic vacuum-assisted closure (eVAC) therapy as their mainstay of treatment. Treatment failure was defined as cervical esophagostomy formation or death. RESULTS: In total, 37 patients developed an anastomotic leakage after esophagectomy with a gastric pull-up reconstruction. Twenty patients were included into the non-eVAC cohort, whereas 17 patients were treated with eVAC. Treatment failure was observed in 50% of patients (n = 10) in the non-eVAC cohort and in 6% of patients (n = 1) in the eVAC cohort (p < 0.05). The 90-day mortality in the non-eVAC cohort was 15% (n = 3) compared to 6% (n = 1) in the eVAC cohort. Cervical esophagostomy formation was required in 40% of cases (n = 8) in the non-eVAC cohort, whereas no patient in the eVAC cohort underwent cervical esophagostomy formation. CONCLUSION: eVAC therapy for leaking esophagogastric anastomoses appears to be superior to other treatment strategies as it significantly reduces morbidity and mortality. Therefore, we suggest eVAC as an essential component in the treatment algorithm for anastomotic leakages following esophagectomies, especially in patients with intrathoracic anastomoses.

The role of vacuum-assisted closure (VAC) therapy in the management of FOURNIER'S gangrene: a retrospective multi-institutional cohort study.

PURPOSE: To explore the role of vacuum assisted closure (VAC) therapy versus conventional dressings in the Fournier's gangrene wound therapy. PATIENTS AND METHODS: This is a retrospective multi-institutional cohort study. Data of 92 patients from nine centers between 2007 and 2018 were retrospectively analyzed. After surgery, patient having a local or a disseminated FG were managed with VAC therapy or with conventional dressings. The 10-weeks wound closure cumulative rate and OS were analyzed. RESULTS: Of the 92 patients, 62 (67.4%) showed local and 30 (32.6%) a disseminated FG. After surgery, 19 patients (20.7%) with local and 14 (15.2%) with disseminated FG underwent to VAC therapy; 43 (46.7%) with local and 16 (17.4%) with disseminated FG were treated using conventional dressings. The multivariable logistic regression analysis demonstrated that the VAC in patients with disseminated FG led to a higher cumulative rate of wound closure than patients treated with no-VAC (OR = 6.5; 95% CI 1.1-37.4, p = 0.036). The Kaplan-Meier survival curves for the OS showed a significant difference between no-VAC patients with local and disseminated FG (OS rate at 90 days 0.90, 95% CI 0.71-0.97 vs 0.55, 95% CI 0.24-0.78, respectively; p = 0.039). Cox regression confirmed that no-VAC patients with disseminated FG showed the lowest OS (hazard ratio adjusted for sex and age HR = 3.4, 95% CI 1.1-10.4; p = 0.033). CONCLUSIONS: In this large cohort study, VAC therapy in patients with disseminated FG may offer an advantage in terms of 10-weeks wound closure cumulative rate and OS at 90 days after initial surgery.

Penetration of echinocandins into wound secretion of critically ill patients.

PURPOSE: Wound infections caused by Candida are life-threatening and difficult to treat. Echinocandins are highly effective against Candida species and recommended for treatment of invasive candidiasis. As penetration of echinocandins into wounds is largely unknown, we measured the concentrations of the echinocandins anidulafungin (AFG), micafungin (MFG), and caspofungin (CAS) in wound secretion (WS) and in plasma of critically ill patients. METHODS: We included critically ill adults with an indwelling wound drainage or undergoing vacuum-assisted closure therapy, who were treated with an echinocandin for suspected or proven invasive fungal infection. Concentrations were measured by liquid chromatography with UV (AFG and MFG) or tandem mass spectrometry detection (CAS). RESULTS: Twenty-one patients were enrolled. From eight patients, serial WS samples and simultaneous plasma samples were obtained within a dosage interval. AFG concentrations in WS amounted to < 0.025-2.25 mg/L, MFG concentrations were 0.025-2.53 mg/L, and CAS achieved concentrations of 0.18-4.04 mg/L. Concentrations in WS were significantly lower than the simultaneous plasma concentrations and below the MIC values of some relevant pathogens. CONCLUSION: Echinocandin penetration into WS displays a high inter-individual variability. In WS of some of the patients, concentrations may be sub-therapeutic. However, the relevance of sub-therapeutic concentrations is unknown as no correlation has been established between concentration data and clinical outcome. Nevertheless, in the absence of clinical outcome studies, our data do not support the use of echinocandins at standard doses for the treatment of fungal wound infections, but underline the pivotal role of surgical debridement.

Vacuum-assisted closure therapy combined with bi-pectoral muscle flap for the treatment of deep sternal wound infections.

Deep sternal wound infection (DSWI) is a fatal complication after median sternotomy. This study was to assess the effect of vacuum-assisted closure (VAC) combined with bi-pectoral muscle advancement flap therapy on rehabilitation for the treatment of DSWI. Fifty-two patients with DSWI underwent treatment of VAC and bi-pectoral muscle flap. These patients were followed-up 12 months postoperation. The patient characteristics, duration of VAC therapy, the mean hospital stay, and postoperative complications were retrospectively analysed. All patients underwent 1 to 3 VAC treatment sessions before closure. Fifty-one of 52 DSWI patients were cured to discharge; the mean hospital stay was 26.5 days. The drainage tube continued to drain a large amount of bloody fluid in three patients after the wound was closed. Respiratory failure occurred in one patient with severe mediastinal and pulmonary infections and died eventually in hospital. One patient died of acute cerebral haemorrhage during the12-month follow-up. VAC therapy combined with bi-pectoral muscle flap is a simple and effective treatment for DSWIs with short hospital stays and few complications. However, this is a retrospective case series presentation with no comparison group; further large-scale controlled studies are needed.

Use of abdominal negative pressure wound therapy in different indications: a case series.

Negative pressure wound therapy (NPWT) is a widely used wound management system. Several articles have been published on the advantages and complications of this system. Abdominal dressing negative pressure system (abdominal NPWT) is a newer technology, developed and used in open abdomen cases. The adherence of the sponge to the intra-abdominal organs is prevented by a polyurethane foam. This study presents a number of case series where an abdominal NPWT (ABThera, KCI, US) has been used to treat other vital organs, helping to prevent complications such as organ rupture and fatal bleeding.

Disseminated fungal infection by Aureobasidium pullulans in a renal transplant recipient.

Renal transplant recipients are on long-term potent immunosuppressive therapy, which makes them highly vulnerable to opportunistic fungal infections. Dematiaceous, or dark-pigmented saprophytic fungi, are being increasingly seen as opportunistic pathogens of mycoses in immunosuppressed patients. One of these is Aureobasidium pullulans, which is a black yeast-like dematiaceous fungus found ubiquitously in the environment that can cause various opportunistic human infections. Most infections occur by traumatic inoculation, such as keratitis and cutaneous lesions; disseminated mycoses are very rare and occur only in severely immunocompromised patients. We report a case of disseminated fungal infection due to A. pullulans in a pediatric patient who underwent renal transplant. The use of voriconazole and vacuum-assisted closure along with surgical drainage most likely contributed to the patient's positive outcome.

Comparative effectiveness study between negative pressure wound therapy and conventional wound dressing on perforator flap at the Chinese tertiary referral teaching hospital.

BACKGROUND: Perforator flap techniques with conventional wound dressing have being extensively used in the management of soft-tissue defects. However; the flap's survival rate is not always guaranteed and the wound healing time always long. The aim of this study was to investigate the clinical effectiveness use of a freshly transplanted perforator flap in conjunction with Vacuum-assisted closure (VAC) for better clinical outcomes. METHODS: A prospective, randomized, effectiveness study comparing the clinical outcomes of VAC versus traditional wrap and bandages for the treatment of open wounds that required hospital admission and operative debridement using perforator flaps, was carried out from March 1, 2014 to March 31, 2016 at Wuhan University Zhongnan Hospital. Fifty-one eligible patients were randomized into two groups; study group (perforator flaps covered by VAC) and control group (perforator flaps covered by traditional wrap and bandages). The measured clinical endpoints included the time of the first post-operative dressing change, pain visual analogical scale, perforator flap infection rate, 95% perforator flap healing time and percentage of survived perforator flap. RESULTS: There was no statistically significant difference in the demographic profiles in the two cohorts. There were statistically significant differences in the clinical endpoints in the two groups (p < 0.001; p < 0.05, Table 2). CONCLUSIONS: In summary, VAC combining with perforator flap technique, can diminish accumulated exudation of the transferring flap, protect against postoperative infection, prolong the interval between perforator flap relocation and first postoperative dressing change, decrease pain during removal of dressing, increase perforator flap survival rate, and shorten wound healing time, with a good aesthetic outcome, a good mobility and a satisfactory therapeutic result.

The effectiveness of negative pressure therapy on infected wounds: preliminary results.

Vacuum-assisted closure (VAC) therapy is a sophisticated system that maintains a closed, humid, sterile and isolated environment. Wound infection is considered a relative contraindication. The objective of this study is to extend the indications for VAC therapy to include infected wounds by demonstrating its ability to increase the antibiotic concentration in the damaged and infected tissues. Patients who presented with ulcers infected with daptomycin-sensitive bacteria were eligible to be enrolled in this prospective study. They were given antibiotic therapy with daptomycin with a specific protocol. A biopsy of the lesion was carried out to detect tissue concentration of the drug at time 0. Afterwards, the patients were subjected to VAC therapy. At the end of VAC therapy, a second lesion biopsy was performed and analysed to detect tissue concentration of the drug at time 1. A control group was enrolled in which patients followed the same protocol, but they were treated with traditional dressings. Fisher's exact test was used to compare the two groups. The results highlighted a significant increase in the concentration of antibiotics in the study group tissue; the improvement was sensibly lower in the control group. Statistical differences were not found between the two groups. The preliminary analysis of the data showed an important increase of antibiotic concentration in the tissue after VAC therapy. Despite the encouraging data, it is necessary to broaden the sample of patients and perform the same study with other antibiotics.

High risk of fistula formation in vacuum-assisted closure therapy in patients with open abdomen due to secondary peritonitis-a retrospective analysis.

PURPOSE: The aim of this study was to evaluate the efficacy of vacuum-assisted closure therapy in patients with open abdomen due to secondary peritonitis and to identify possible risk factors of fistula formation. METHODS: The hospital OPS-database (time period 2005-2014) was searched to identify patients treated with an open abdomen due to secondary peritonitis, who underwent vacuum-assisted closure therapy. Medical records were retrospectively analyzed for patients' characteristics, cause of peritonitis, duration of vacuum therapy, number of relaparotomies, fascial closure rates, and risk factors of fistula formation. RESULTS: Forty-three patients (19 male, 24 female) with a median age of 65 years (range 24-90 years) were identified. The major cause of secondary peritonitis was anastomotic leakage after intestinal anastomosis or bowel perforation, the median APACHE II score was 11. Median duration of VAC treatment was 12 days (range 3-88 days). Twenty of 43 (47 %) patients died from septic complications. Delayed fascial closure was obtained by suturing in 20 of 43 patients (47 %). Overall 16 of 43 (37 %) patients developed enteroatmospheric fistulas. Re-explorations after starting VAC treatment and duration of VAC therapy were significantly associated with the occurrence of enteroatmospheric fistulas (p < 0.001). ROC curve analysis determined the optimal duration of VAC therapy to reduce the risk of fistula formation at 13 days. CONCLUSIONS: Long-term VAC treatment of patients with an open abdomen due to secondary peritonitis results in a relatively low fascial closure rate and a high risk of fistula formation.

Negative pressure wound therapy in the early period after hand and forearm replantation, is it safe?

OBJECTIVE: In this study, effectiveness and reliability of negative pressure wound therapy (NPWT) in the early period after replantation will be examined retrospectively in a series of patients. METHOD: Patients who underwent replantation between 2007 and 2014, and had tissue defect or partial necrosis in the absence of a major circulation problem were included in this retrospective study. Following debridement of necrotic tissues on the postoperative 7-10 days, NPWT was applied to all patients one day later and adjusted as intermittent 75 mmHg pressure. Intermittent phase adjustment was arranged as 5 minutes suction and 2 minutes resting, and resting pressure was adjusted as 35 mmHg. NPWT was applied for six days and dressings were changed in every three days in the first six day period. Open wounds was debrided again and grafted with split-thickness skin graft and NPWT was continued over the graft for 4 days more. RESULTS: There were 11 patients included of which nine amputations were complete and two were nearly total amputations of forearm. Granulation tissue was observed following 6 days of NPWT application in all patients. Graft survival was observed to be almost complete. Wound infection did not occur and tissue cultures obtained in the course of debridement were all negative. Partial oxygen saturations were between 96-99% during the NPWT. CONCLUSION: NPWT (75 mmHg) can be used in the intermittent mode in order to improve wound healing and shorten the period to start physical therapy in the early period after replantation and revascularisation.

VAC therapy to promote wound healing after surgical revascularisation for critical lower limb ischaemia.

Vacuum-assisted closure (VAC) therapy is a new emerging non-invasive system in wound care, which speeds up wound healing by causing vacuum, improving tissue perfusion and suctioning the exudates, and facilitating the removal of bacteria from the wound. The application of sub-atmospheric pressure on the lesions seems to alter the cytoskeleton of the cells on the wound bed, triggering a cascade of intracellular signals that increase the rate of cell division and subsequent formation of granulation tissue. The aim of this study is to analyse the results of VAC therapy used as an adjuvant therapy for the treatment of foot wounds in patients affected by critical limb ischaemia (CLI) (Rutherford 6 class) after distal surgical revascularisation, to promote and accelerate the healing of ulcers. Twenty-nine patients (20 males, 9 females; mean age 68·4) affected by CLI of Rutherford 6 class, after surgical revascularisation of the lower limb, underwent VAC therapy in order to speed up wound healing. Complete wound healing was achieved in 19 patients (65·51%), in an average period of 45·4 ± 25·6 days. VAC therapy is a valid aid, after surgical revascularisation, to achieve rapid healing of foot lesions in patients with CLI.

Successful combined approach to a severe Fournier's gangrene.

We present a case of a successful reconstruction of a severe Fournier's gangrene (FG) involving the scrotum, the perineum, the right ischial area and extended to the lower abdomen. There are many different surgical techniques to repair and reconstruct the defect following debridement in FG. The authors treated this complex wound using negative pressure wound therapy (NPWT), dermal regeneration template and a split-thickness skin graft. Complete recovery was achieved and no major complications were observed. The patient showed a satisfying functional and aesthetic result.

Adapting surgical 'bundles' to prevent surgical site infections in obstetrics and gynecology (Review).

Surgical site infections (SSIs) are a complication in any surgical field and they are responsible for 38% of surgery-related patient deaths. Identifying appropriate prophylaxis and solutions to combat SSIs is of global interest. Several studies and reports on SSI raise awareness of this costly complication, both in terms of physical and mental suffering, and as a monetary burden. Knowing the risk factors and implementing strategies to reduce SSI risk represent an adequate approach to reduce SSI incidence. General risk factors of SSI are applicable in the obstetrics and gynecology field, alongside its specific characteristics, including immunological changes occurring during pregnancy, as well as disturbances of vaginal microbiota. The risk of SSI is determined by patient factors but also by preoperative, intraoperative and postoperative care. 'Bundle' prevention strategies have been smartly adopted and their efficiency has been demonstrated in colorectal surgery, cesarean deliveries and gynecological oncology surgeries. 'Bundle' measures may vary among studies, but they remain important prevention methods, which contribute to decreasing SSIs, which is a favorable outcome, and thus, are increasingly used as a routine practice. Therefore, healthcare personnel should aim for the early identification of risk factors to minimize the risk of SSI. All evidence-based methods for preventing and treating SSIs in all surgical fields should be considered to be integral components in order for the best care to be provided to patients.

The effectiveness of vacuum-assisted closure therapy in patients with infected venous leg ulcers.

AIM: In this study, we aimed to investigate the effect of vacuum-assisted closure therapy on venous stasis wound healing in patients with chronic venous leg ulcers. METHODS: Vacuum-assisted closure therapy was applied on a total of 14 venous leg ulcers. All patients had post-thrombotic syndrome. Quantitative wound culture samples were obtained before the procedure and local wound assessments were performed. The primary outcome measures included wound healing as assessed by a local wound examination during each dressing change and the rate and velocity of ulcer reduction. Wound healing was defined as the complete closure of the ulcer, while rapid wound healing was defined as a ≥ 30% reduction in the ulcer size by week four. RESULTS: No surgical debridement or surgical corrective procedure was applied in any patient. The mean length of hospital stay was 32.3 days. The mean number of vacuum-assisted closure therapies for each case was 17.8 and the mean time to dressing change was 72.3 hours. Multidrug-resistant Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus were detected in three and four patients, respectively. Wound culture results became negative after a mean duration of vacuum-assisted closure therapy of 12.1 days. None of the patients needed antibiotic therapy until the procedure was completed. Compared to baseline, the mean ulcer reduction rates were 46.4% for the first six applications and 72.8% for the subsequent applications. CONCLUSIONS: Our study results suggest that vacuum-assisted closure therapy promotes rapid wound healing in patients with severe post-thrombotic syndrome with venous stasis leg ulcers, and reduces the need for antibiotics by reducing the biological burden.

Treatment of Fournier's Gangrene With Vacuum-assisted Closure Therapy as Enhanced Recovery Treatment Modality.

BACKGROUND/AIM: Fournier's gangrene is an uncommon, but extremely serious condition of necrotizing, soft tissue infection. There is a great debate regarding the management of larger defects and wound closure, with various techniques being described in the current literature. We aimed to present the surgical management of extensive Fournier's gangrene treated successfully with Vacuum-assisted closure (VAC) therapy, a novel approach to treatment algorithm that can lead to a paradigm shift. CASE: A 66-year-old male patient with Fournier's gangrene was treated with extensive surgical debridement, protective colostomy and VAC therapy. RESULTS: After initial extensive surgical debridement, VAC therapy significantly improved the clinical and aesthetic condition of the patient. CONCLUSION: VAC therapy in Fournier's gangrene patients may be a safe and effective technique with favorable clinical outcomes, by improving and enhancing wound healing and recovery.

A novel approach to resolve severe mediastinal and subcutaneous emphysema occurring in Pneumocystis jirovecii pneumonia using vacuum-assisted closure therapy.

A 50-year-old human immunodeficiency virus positive patient who was diagnosed with Pneumocystis jirovecii pneumonia developed severe subcutaneous and mediastinal emphysema, which was progressive despite low pressure mechanical ventilation. Infraclavicular skin incisions and vacuum-assisted closure therapy were used to resolve the emphysema. The subcutaneous emphysema decreased significantly, and after 1 week the vacuum-assisted closure therapy was ended successfully. This technique has previously been described in several case reports, where it is a promising treatment in severe subcutaneous emphysema, but it is not yet widely used. This case report supports the further use of vacuum-assisted closure therapy in subcutaneous emphysema. Successful treatment of severe mediastinal and subcutaneous emphysema in Pneumocystis jirovecii pneumonia can be achieved by vacuum-assisted closure therapy on infraclavicular skin incisions.

Vacuum-assisted closure vs. bilateral pectoralis major muscle flaps for deep sternal wounds infection.

BACKGROUND: Deep sternal wound infection (DSWI) is a life-threatening complication after cardiac surgery. The aim of this study was to retrospectively evaluate the outcomes of reconstructing infected poststernotomy wounds with either vacuum-assisted closure (VAC) after previous debridement or bilateral pectoralis major muscle flaps (BPMMFs). METHODS: In total, 565 patients with postoperative DSWI were enrolled in this study from January 1, 2014, to June 1, 2018. Of these patients, 247 received BPMMFs. To address the indicated biases, a 1:1 propensity score-matched cohort was created based on age, body mass index, preoperative diabetes mellitus, chronic obstructive pulmonary disease (COPD), internal thoracic artery grafting (ITAG), type of cardiac surgery, time before treatment for DSWI and wound classification. After matching, 132 patients who had similar risk profiles were enrolled in the study population (66 in the VAC group: 66 in the BPMMF group). RESULTS: At 21.9±12.1 (median: 24, IQR: 14-28) months of follow-up, the survival rate was 93.9% in the BPMMF group and 74.4% in the VAC group (P<0.01). Compared with the VAC group, the BPMMF group had a significantly decreased length of hospital stay (P<0.01). At the spirometry assessment, the forced expiratory volume in the 1st second (FEV1), vital capacity (VC), and FEV1/VC ratio showed no significant differences in survival between the VAC group and BPMMF group. CONCLUSIONS: In our study, compared with VAC therapy, BPMMFs guaranteed better early- and late-term outcomes, as shown by less length of hospital stay, a higher rate of long-term survival and unimpaired respiratory function.

Bilateral-pectoral major muscle advancement flap combined with vacuum-assisted closure therapy for the treatment of deep sternal wound infections after cardiac surgery.

OBJECTIVES: The median sternotomy is the most common surgical approach for cardiac surgery. Deep sternal wound infection is a fatal complication after median sternotomy. The aim of this study was to evaluate the therapeutic effect of Bilateral-pectoral major muscle advancement flap combined with Vacuum-assisted closure therapy on rehabilitation for the treatment of deep sternal wound infection after cardiac surgery. METHODS: Between January 2016 to January 2018, 21 patients (10 males, 11 females) with deep sternal wound infection after cardiac surgery underwent Bilateral-pectoral major muscle advancement flap combined with Vacuum-assisted closure therapy. These patients were followed-up 12 months postoperative. The patient characteristics, duration of vacuum-assisted closure therapy, the mean hospital stay, postoperative complications, long-term survival of patients were retrospectively analyzed. RESULTS: Most patients undergone 1-3 times vacuum-assisted closure treatment sessions before closure. All patients were cured to discharge, the mean hospital stay was 21.1 days. Most patients' healing wounds were first-stage healing, only one patient's wound was second-stage healing, none was third-stage healing. One patient developed pulmonary infection and respiratory failure during the 12-month follow-up. None of the patients died during follow-up. CONCLUSIONS: Bilateral-pectoral major muscle advancement flap combined with Vacuum-assisted closure therapy for the treatment of deep sternal wound infections after cardiac surgery can shorten the hospital stays and few complications. However, this is a retrospective case series presentation with no comparison group, the number of inferences is limited, so further large-scale controlled studies are needed.

Vacuum-assisted closure versus closed irrigation for deep sternal wound infection treatment in infants: a propensity score-matched study.

OBJECTIVES: This study aimed to compare vacuum-assisted closure therapy (VAC) and closed irrigation drainage therapy (CID) for deep sternal wound infection treatment in infants. METHODS: From January 2008 to March 2018, 69 patients (1.73%) had deep sternal wound infection. They were divided into 2 groups: patients treated with VAC therapy (VAC group, 29 patients) and those treated with CID therapy (CID group, 40 patients). After performing a propensity score analysis (1:1) for the entire sample, 16 patients receiving VAC therapy were matched with 16 patients receiving CID therapy. RESULTS: No significant difference was noted between both groups regarding age [d = 0.045; 95% confidence interval (CI) 0.99-1.07], gender (d = 0.001; 95% CI 0.22-4.45), weight (d = 0.011; 95% CI 0.73-1.35), body surface area (d = -0.023; 95% CI 0.01-5733.08), cardiopulmonary bypass (d = 0; 95% CI 0.16-5.90) and open chest duration (d = -0.112; 95% CI 0.31-5.16). Five patients died in the CID group (31.25%) during hospital stay, and there were no deaths in the VAC group (P = 0.024). Recurrence of mediastinitis occurred in 1 patient (6.25%) from the VAC group and in 6 patients (37.5%) from the CID group (P = 0.037). The multivariable regression analysis revealed that the CID method was the only risk factor for remediastinitis (odds ratio 17.3; 95% CI 1.04-286.75; P = 0.046). CONCLUSIONS: Use of VAC therapy in infants with deep sternal wound infection was associated with a substantial decrease in the mortality rate and duration of therapy compared with CID technique. The CID technique was an independent risk factor for recurrence of mediastinitis.

Comparison of Vacuum-Assisted Closure Therapy and Conventional Dressing on Wound Healing in Patients with Diabetic Foot Ulcer: A Randomized Controlled Trial.

BACKGROUND: Vacuum-assisted closure (VAC) therapy has been shown to be beneficial in a variety of wounds. However, evidence of its benefit in diabetic foot ulcers (DFUs), especially with respect to Indian population, is sparse. METHODOLOGY: This randomized controlled trial included DFUs of Wagner's Grades 1 and 2. Patients were further stratified with respect to DFU size <10 cm and ≥10 cm. Patients with vascular disease, osteomyelitis, and bilateral DFUs were excluded from the study. The enrolled patients were randomized to receive VAC therapy or conventional dressing. The time to wound healing, granulation tissue formation, and complications such as pain, infection, and bleeding were compared between the two groups. RESULTS: A total of sixty patients were randomized, of which 27 in each group were analyzed. The mean time to healing in days was significantly less in VAC group (22.52 vs. 3.85; P < 0.0001). Mean time to achieve 75%-100% granulation tissue cover was significantly less in VAC group (23.33 vs. 32.15; P < 0.0001). Rate of granulation tissue formation was also found to be significantly better in VAC group (2.91 cm2/day vs. 2.16 cm2/day; P = 0.0306). There was no difference between the two groups with respect to wound infection and bleeding which are commonly attributed to VAC therapy. VAC therapy group had significantly lesser pain at week 3 (Visual Analog Scale score 3 vs. 4; P = 0.004). CONCLUSION: VAC therapy significantly decreases the time to complete wound healing, hastens granulation tissue formation, and reduces the ulcer area compared to conventional dressing. The study did not find any significant increase in the bleeding and infection in the VAC therapy group.