Ambulatory negative pressure wound therapy of subcutaneous abdominal wounds after surgery: results of the SAWHI randomized clinical trial.

BACKGROUND: The SAWHI study showed that negative pressure wound therapy (NPWT) reduced treatment time by 7.8 days and had a 20.2% higher wound closure rate, but required a 2.1-day longer hospital stay than conventional wound treatment (CWT). The majority of study participants began treatment in the hospital and were discharged within 42 days. METHODS: As an add-on to a multicenter randomized clinical trial, selected aspects of hospital discharge, outpatient treatment continuation, and subsequent wound closure outcomes are compared between the treatment arms in patients with subcutaneous abdominal wound healing impairment after surgery without fascia dehiscence in the per protocol population. RESULTS: Within 42 days, wound closure rates were higher for outpatients in the NPWT arm than for outpatients in the CWT arm (27 of 55 [49.1%]) for both outpatient continuation of NPWT (8 of 26 [30.8%]) and outpatient CWT after NPWT was finished (27 of 121 [22.3%]). Time to wound closure was shorter for outpatients in the NPWT arm (outpatient transfer with: NPWT Mean ± standard error 28.8 ± 8.0 days; CWT 28.9 ± 9.5 days) than in the conventional treatment arm (30.4 ± 8.0 days). Nevertheless, within 30 study sites with patient enrollment, outpatient NPWT was performed in only 20 study sites for 65 of 157 study participants in the treatment arm. CONCLUSIONS: Outpatient NPWT of postsurgical abdominal wounds with healing impairment is feasible and successful and should be encouraged whenever possible. Study site specific avoidance of outpatient NPWT emerges as an additional reason for the prolonged hospitalization time. Trial Registration ClinicalTrials.gov Identifier NCT01528033. Date of registration: February 7, 2012, retrospectively registered.

NPWT resource use compared with standard moist wound care in diabetic foot wounds: DiaFu randomized clinical trial results.

BACKGROUND: Diabetic foot ulcers not only have a negative impact on patient mortality, morbidity and quality of life, but also require high resource utilization to achieve complete wound healing. The aim of this evaluation was to compare resource utilization of negative pressure wound therapy (NPWT) and standard moist wound care (SMWC) for diabetic foot wounds after amputation, surgical debridement or wound cleansing. METHODS: The multicenter clinical DiaFu study enrolled 368 adults with diabetic foot ulcers between December 23, 2011 and October 21, 2014. Patients were randomly assigned to NPWT and SMWC. Evaluation of direct resource use comprised inpatient and outpatient treatment time, and personnel and material for wound treatment within 16 weeks. This resource use analysis was primarily based on the per protocol population (NPWT 44; SMWC 110). RESULTS: Treatment duration was 16 days shorter with NPWT (mean (SD) 82.8 (31.6), SMWC 98.8 (24.6); U test, p = 0.001) with 14.9 days shorter outpatient treatment (mean (SD) NPWT 68.3 (31.1), SMWC 83.2 (29.7)). The number of dressing changes per study participant was lower with NPWT (mean (SD) 35.1 (18.6), SMWC (42.9 (21.4); U test, p = 0.067). Time per dressing change was significantly lower with SMWC (mean (SD) 19.7 (12.8), NPWT (16.5 (8.2) minutes; U test, p < < 0.0001). Time for surgical debridements per study participant was 23.3 minutes shorter with NPWT (mean (SD) 20.5 (20.5), SMWC (43.8 (46.7); U test, p = 0.395). CONCLUSIONS: Resource use was lower for NPWT, which may be an efficient treatment alternative to SMWC for diabetic foot wounds, to be demonstrated in subsequent cost analyses. TRIAL REGISTRATION: clinicaltrials.gov NCT01480362 on November 28, 2011.

NPWT Resource Use Compared With Conventional Wound Treatment in Subcutaneous Abdominal Wounds With Healing Impairment After Surgery: SAWHI Randomized Clinical Trial Results.

OBJECTIVE: To compare resource utilization of NPWT and CWT for SAWHI after surgery. SUMMARY OF BACKGROUND DATA: NPWT is widely used in the management of complex wounds but high-level evidence of its resource use remains sparse. METHODS: The multicenter, multinational, randomized clinical SAWHI study enrolled a total of 539 consecutive, compliant adult patients with SAWHI after surgery without fascial dehiscence between August 2, 2011, and January 31, 2018. Patients were randomly assigned to NPWT and CWT stratified by study site and wound size using a centralized web-based tool. Evaluation of direct resource use comprised inpatient and outpatient time, personnel and material for wound treatment, and associated wound-related procedures. The resource use analysis was primarily based on the per protocol population (NPWT 157; CWT 174). RESULTS: Although treatment length within 42 days was significantly shorter in the NPWT arm {Mean [Standard deviation (SD)] NPWT 22.8 (13.4); CWT 30.6 (13.3); P < 0.001 U-test}, hospitalization time was shorter with CWT [Mean (SD) NPWT 13.9 (11.1); CWT 11.8 (10.8); P = 0.047 U-test]. Significantly more study participants were outpatient with CWT [N=167 (96.0%)] than with NPWT [N = 140 (89.2%) (P = 0.017)]. Time for dressing changes per study participant [Mean (SD) (min) NPWT N = 133, 196 (221.1); CWT N = 152, 278 (208.2); P < .001 U-test] and for wound-related procedures [Mean (SD) (min) NPWT 167 (195); CWT 266 (313); P < 0.001 U-test] was significantly lower with NPWT. CONCLUSIONS: NPWT reduces resource use and maybe an efficient treatment alternative to CWT for SAWHI after surgery.

Synthetic Versus Biological Mesh in Laparoscopic and Open Ventral Hernia Repair (LAPSIS): Results of a Multinational, Randomized, Controlled, and Double-blind Trial.

OBJECTIVE: The aim of this study was to investigate the approach (open or laparoscopic) and mesh type (synthetic or biological) in ventral hernias in a clean setting.Summary of Background Data: The level of evidence on the optimal surgical approach and type of mesh in ventral hernia repair is still low. METHODS: Patients with a ventral abdominal hernia (diameter 4-10 cm) were included in this double-blind randomized controlled trial across 17 hospitals in 10 European countries. According to a 2 × 2-factorial design, patients were allocated to 4 arms (open retromuscular or laparoscopic intraperitoneal, with synthetic or Surgisis Gold biological mesh). Patients and outcome assessors were blinded to mesh type used. Major postoperative complication rate (hernia recurrence, mesh infection, or reoperation) within 3 years after surgery, was the primary endpoint in the intention-to-treat population. RESULTS: Between September 1st, 2005, and August 7th, 2009, 253 patients were randomized and 13 excluded. Six of 61 patients (9.8%) in the open synthetic mesh arm, 15 of 66 patients (22.7%) in the open biological mesh arm, 7 of 64 patients (10.9%) in the laparoscopic synthetic mesh arm and 17 of 62 patients (27.4%) in the laparoscopic biological mesh arm had a major complication. The use of biological mesh resulted in significantly more complications (P = 0.013), also after adjusting for hernia type, body mass index, and study site. The trial was prematurely stopped due to an unacceptable high recurrence rate in the biological mesh arms. CONCLUSIONS: The use of Surgisis Gold biological mesh is not recommended for noncomplex ventral hernia repair. TRIAL REGISTRATION: This trial was registered at controlled-trials.com (ISRCTN34532248).

Negative Pressure Wound Therapy vs Conventional Wound Treatment in Subcutaneous Abdominal Wound Healing Impairment: The SAWHI Randomized Clinical Trial.

Importance: Negative pressure wound therapy (NPWT) is an established treatment option, but there is no evidence of benefit for subcutaneous abdominal wound healing impairment (SAWHI). Objective: To evaluate the effectiveness and safety of NPWT for SAWHI after surgery in clinical practice. Design, Setting, and Participants: The multicenter, multinational, observer-blinded, randomized clinical SAWHI study enrolled patients between August 2, 2011, and January 31, 2018. The last follow-up date was June 11, 2018. The trial included 34 abdominal surgical departments of hospitals in Germany, Belgium, and the Netherlands, and 539 consecutive, compliant adult patients with SAWHI after surgery without fascia dehiscence were randomly assigned to the treatment arms in a 1:1 ratio stratified by study site and wound size using a centralized web-based tool. A total of 507 study participants (NPWT, 256; CWT, 251) were assessed for the primary end point in the modified intention-to-treat (ITT) population. Interventions: Negative pressure wound therapy and conventional wound treatment (CWT). Main Outcomes and Measures: The primary outcome was time until wound closure (delayed primary closure or by secondary intention) within 42 days. Safety analysis comprised the adverse events (AEs). Secondary outcomes included wound closure rate, quality of life (SF-36), pain, and patient satisfaction. Results: Of the 507 study participants included in the modified ITT population, 287 were men (56.6%) (NPWT, 155 [60.5%] and CWT, 132 [52.6%]) and 220 were women (43.4%) (NPWT, 101 [39.5%] and CWT 119 [47.4%]). The median (IQR) age of the participants was 66 (18) years in the NPWT arm and 66 (20) years in the CWT arm. Mean time to wound closure was significantly shorter in the NPWT arm (36.1 days) than in the CWT arm (39.1 days) (difference, 3.0 days; 95% CI 1.6-4.4; P < .001). Wound closure rate within 42 days was significantly higher with NPWT (35.9%) than with CWT (21.5%) (difference, 14.4%; 95% CI, 6.6%-22.2%; P < .001). In the therapy-compliant population, excluding study participants with unauthorized treatment changes (NPWT, 22; CWT, 50), the risk for wound-related AEs was higher in the NPWT arm (risk ratio, 1.51; 95% CI, 0.99-2.35). Conclusions and Relevance: Negative pressure wound therapy is an effective treatment option for SAWHI after surgery; however, it causes more wound-related AEs. Trial Registration: ClinicalTrials.gov Identifier: NCT01528033.

Negative pressure wound therapy compared with standard moist wound care on diabetic foot ulcers in real-life clinical practice: results of the German DiaFu-RCT.

OBJECTIVES: The aim of the DiaFu study was to evaluate effectiveness and safety of negative pressure wound therapy (NPWT) in patients with diabetic foot wounds in clinical practice. DESIGN: In this controlled clinical superiority trial with blinded outcome assessment patients were randomised in a 1:1 ratio stratified by study site and ulcer severity grade using a web-based-tool. SETTING: This German national study was conducted in 40 surgical and internal medicine inpatient and outpatient facilities specialised in diabetes foot care. PARTICIPANTS: 368 patients were randomised and 345 participants were included in the modified intention-to-treat (ITT) population. Adult patients suffering from a diabetic foot ulcer at least for 4 weeks and without contraindication for NPWT were allowed to be included. INTERVENTIONS: NPWT was compared with standard moist wound care (SMWC) according to local standards and guidelines. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome was wound closure within 16 weeks. Secondary outcomes were wound-related and treatment-related adverse events (AEs), amputations, time until optimal wound bed preparation, wound size and wound tissue composition, pain and quality of life (QoL) within 16 weeks, and recurrences and wound closure within 6 months. RESULTS: In the ITT population, neither the wound closure rate (difference: n=4 (2.5% (95% CI-4.7% - 9.7%); p=0.53)) nor the time to wound closure (p=0.244) was significantly different between the treatment arms. 191 participants (NPWT 127; SMWC 64) had missing endpoint documentations, premature therapy ends or unauthorised treatment changes. 96 participants in the NPWT arm and 72 participants in the SMWC arm had at least one AE (p=0.007), but only 16 AEs were related to NPWT. CONCLUSIONS: NPWT was not superior to SMWC in diabetic foot wounds in German clinical practice. Overall, wound closure rate was low. Documentation deficits and deviations from treatment guidelines negatively impacted the outcome wound closure. TRIAL REGISTRATION NUMBERS: NCT01480362 and DRKS00003347.

Correction to: Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial.

After publication of the original article [1], the authors have notified us that their originally submitted Table 1 was mistakenly replaced with Fig. 3 during editing. The original article has been corrected.The publisher apologizes to the readers for the inconvenience caused.

Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial.

BACKGROUND: Symptomatic hemorrhoids are one of the most common anorectal disorders. Many surgeons use tamponades after open hemorrhoidectomy to manage postoperative bleeding. The question of whether a tamponade is necessary and beneficial after hemorrhoidectomy has not yet been conclusively answered. A previously conducted single-center pilot trial included 100 patients after Milligan-Morgan hemorrhoidectomy. The data indicated that insertion of an anal tamponade after hemorrhoidectomy does not reduce postoperative bleeding but causes significantly more pain. The findings of this pilot trial are now to be verified by means of a multicenter randomized clinical study called NoTamp. METHODS: We plan to include 953 patients after Milligan-Morgan or Parks hemorrhoidectomy in the NoTamp study. The aim is to demonstrate that using no tamponade dressing after open hemorrhoidectomy is not inferior to using tamponades with respect to postoperative bleeding, and that the patients report less pain. Primary endpoints of the trial are the maximum postoperative pain within 48 h and the incidence of severe postoperative bleeding that requires surgical revision within 7 days after the surgical procedure. Secondary endpoints of the study are the use of analgesics in the postoperative course, the lowest hemoglobin documented within 7 days, quality of life and patient satisfaction. Safety analysis includes all adverse and serious adverse events in relation to the study treatment. Further information can be found in the registration at the German Registry of Clinical Studies (DRKS00011590) and on the study webpage ( https://notamp.de/en-GB/trial/main/setLocale/en_GB/ ). The study is financed by the HELIOS research funding. DISCUSSION: The study received full ethics committee approval. The first patient was enrolled on 3 May 2017. This trial will finally answer the question whether the insertion of a tamponade after open hemorrhoidectomy is necessary and beneficial. TRIAL REGISTRATION: German Clinical Trials Register (Deutsches Register Klinischer Studien (DRKS), DRKS00011590 . Registered on 12 April 2017.

[Statement: Requirements for the assessment of surgical innovations]. / Statement: Anforderungen an Methoden zur Bewertung chirurgischer Innovationen.

The term "innovation" refers to new products, but also to the process of developing and distributing new products and procedures. The operative disciplines are often associated with innovations because of their continuous, stepwise adaptation of daily practice to established procedures. Medical devices play a significant role in integrating surgical technology with surgical experience. The success of a surgical innovation and other invasive treatments does not only depend on the surgical procedure, but also on the context of the whole treatment process including the pre- and postoperative phase, the interaction of the surgical team and the setting. High standards have been set for the assessment of surgical innovations in terms of patient safety, efficacy and patient benefit, which will be discussed in the present paper. A stepwise approach to evaluation will be used, split into preclinical development, clinical development (feasibility and safety), evaluation phase (efficacy and patient benefit) and longtime surveillance. Our paper is based on the expert-based consented IDEAL approach as well as the consented recommendations of the European Association of Endoscopic Surgery (EAES). (As supplied by publisher).

Negative pressure wound therapy versus standard wound care in chronic diabetic foot wounds: study protocol for a randomized controlled trial.

BACKGROUND: In August 2010, the Federal Joint Committee (G-BA) decided that negative pressure wound therapy (NPWT) would not be reimbursable in German ambulatory care. This decision was based on reports from the Institute for Quality and Efficiency in Health Care (IQWiG), which concluded that there is no convincing evidence in favor of NPWT. The aim of this diabetic foot study (DiaFu study) is to evaluate whether the clinical, safety and economic results of NPWT are superior to the results of standard wound treatment. METHODS/DESIGN: The DiaFu study is designed as a national, multicenter, randomized controlled clinical superiority trial with a special focus on outpatient care in Germany. Competent patients in inpatient and outpatient care suffering from a chronic diabetic foot wound for a minimum of four weeks may be included in the study. The trial evaluates the treatment outcome of the application of a technical medical device which is based on the principle of NPWT (intervention group) in comparison to standard moist wound therapy (control group). All treatment systems used in the intervention group bear the symbol of free trade capacity in the European Union (CE mark) and will be operated within normal conditions of clinical routine and according to manufacturer's instructions. Primary endpoints are the time to complete wound healing and the rate of wound healing achieved in each group within the maximum study treatment time of 16 weeks. Primary endpoints will be confirmed by blinded assessment of wound photographs. DISCUSSION: The DiaFu study will provide solid evidence regarding the efficacy and effectiveness of NPWT until 31 December 2014, the date when G-BA plans to decide on future reimbursement of NPWT in both ambulatory and in-hospital care. The study is designed to comply with all quality requirements of G-BA and IQWiG and will contribute to evidence-based wound care in Germany. The study has been initiated by the statutory health insurance companies in Germany and is co-funded by two manufacturers of NPWT systems. TRIAL REGISTRATION: Clinical Trials.gov registration number: NCT01480362 (date of registration: 23 November 2011).German Clinical Trials Register number: DRKS00003347 (date of registration: 22 November 2011).

Treatment of subcutaneous abdominal wound healing impairment after surgery without fascial dehiscence by vacuum assisted closure™ (SAWHI-V.A.C.®-study) versus standard conventional wound therapy: study protocol for a randomized controlled trial.

BACKGROUND: A decision of the Federal Joint Committee Germany in 2008 stated that negative pressure wound therapy is not accepted as a standard therapy for full reimbursement by the health insurance companies in Germany. This decision is based on the final report of the Institute for Quality and Efficiency in Health Care in 2006, which demonstrated through systematic reviews and meta-analysis of previous study projects, that an insufficient state of evidence regarding the use of negative pressure wound therapy for the treatment of acute and chronic wounds exists. Further studies were therefore indicated. METHODS/DESIGN: The study is designed as a multinational, multicenter, prospective randomized controlled, adaptive design, clinical superiority trial, with blinded photographic analysis of the primary endpoint. Efficacy and effectiveness of negative pressure wound therapy for wounds in both medical sectors (in- and outpatient care) will be evaluated. The trial compares the treatment outcome of the application of a technical medical device which is based on the principle of negative pressure wound therapy (intervention group) and standard conventional wound therapy (control group) in the treatment of subcutaneous abdominal wounds after surgery. The aim of the SAWHI-VAC® study is to compare the clinical, safety and economic results of both treatment arms. DISCUSSION: The study project is designed and conducted with the aim of providing solid evidence regarding the efficacy of negative pressure wound therapy. Study results will be provided until the end of 2014 to contribute to the final decision of the Federal Joint Committee Germany regarding the general admission of negative pressure wound therapy as a standard of performance within both medical sectors. TRIAL REGISTRATION: Clinical Trials.gov NCT01528033German Clinical Trials Register DRKS00000648.

Rotational bed therapy after blunt chest trauma: a nationwide online-survey on current concepts of care in Germany.

INTRODUCTION: Blunt chest injuries are amongst the most life threatening injuries in adult multiple trauma patients. Nevertheless, the treatment of these thoracic injuries has not been standardized yet. Previous publications have reported on the prevention and the treatment of respiratory complications by using continuous lateral rotational bed therapy (CLRT), but there is still a lack of information using this approach in the presence of pulmonary contusions. Therefore current literature indicates a variety of treatment protocols and its use is contended. METHODS: We submitted a 32-item online-questionnaire to 155 hospitals participating in the nationwide TraumaNetwork to assess current treatment concepts in multiple trauma patients suffering from blunt chest trauma including lung contusions with particular focus on the use of CLRT. Overall, 21 level I, 53 level II and 81 level III trauma centres were contacted. The questionnaire was created using "interview 123 5.5.b.de ND6". RESULTS: The overall response rate was 35.5% (55/155) and responses were received from 10 level I (47.6%), 17 level II (32.1%) and 24 level III (29.6%) trauma centres. Thirty-five of the responders (63.6%) declared to be able to perform lateral rotational bed therapy. For level I and II trauma centres more than 80% were able to apply kinetic positioning in contrast to only 50% of level III trauma centres. Although 42.9% of the participants reported on the existence of standardized treatment protocols, 57.1% failed to report a standardized operating procedure for CLRT. The annual mean number of patients per centre treated via CLRT was 15 (0-130). Treatment modalities such as PEEP and the duration of CLRT also showed great variability. Against this background three out of four centres declared an urgent need for further clinical research in the field. CONCLUSIONS: Our data reflect the wide range of different CLRT treatment strategies performed for blunt pulmonary trauma involving lung contusions in German trauma centres. We conclude that a high-quality randomized-controlled trial is warranted to critically assess the role of CLRT in multiple trauma patients with blunt chest trauma to provide a sound basis for future clinical guidelines.