Dataset Information

Effect of Negative Pressure Therapy on Open Abdomen Treatments. Prospective Randomized Study With Two Commercial Negative Pressure Systems.

ABSTRACT: Introduction: The use of negative pressure dressings for open abdominal therapy has made a great impact on strategies for open abdominal treatment. Observed intestinal damage and developement of fistula formation raises questions about safety of commonly used systems (AB-Thera). The most common used system uses foils for shielding intestines directly from negative pressure. As an alternative a system with open pore dressing in double layer film was introduced (Suprasorb CNP) and proved to safe in animal studies. We compared the effects of this two systems on patients requiring open abdominal treatment. Materials and methods: Patients with secondary peritonitis in at least two abdominal quadrants were included in this randomized study. Inclusion criteria were secondary peritonitis (ACS), abdominal compartment syndrome, and abdominal trauma combined with ACS and/or contaminated abdomen. Patients with active bleeding and pancreatitis were not included. We examined Mannheim peritonitis Index (MPI), bloodcount, PCT, amount of fluid collected, and morphological changes on the bowel. Data were collected on day 2, 4, 7, 14, 21, and 28. Primary end point was fascial closure. Examination was terminated in case of death and damage to the abdominal organs. Groups were compared using Mann Whitney U-test and chi square test. Trend evaluation was evaluated using an one way repeated measure analysis of variance. P-values below 0.05 was considered significat. Results: Thirty four patients were included between August 2010 and September 2012. There were no significant difference between two groups in MPI, age, and gender. Mean duration of treatment, WBC, CRP, and abdominal closure rate were not significantly different between groups. Suprasorb CNP System collected twice more fluid than AB-Thera and decreased PCT on significantly faster rate than AB-Thera. Four patients died (11%) and four patients developed enteric fistula (11%). Closure rate was achieved in 27 out of 34 Patients (79.5%). Closure rate was not significantly different between groups. Conclusion: The use of both systems proved to be efficient and safe. The application of well-dosed, moderate negative pressure on contaminated areas of the abdomen seems to have a lot of potential and it is worth directing greater research potential in this direction.

SUBMITTER: Auer T

PROVIDER: S-EPMC7894571 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Effect of Negative Pressure Therapy on Open Abdomen Treatments. Prospective Randomized Study With Two Commercial Negative Pressure Systems.

Auer Thomas T Sauseng Siegfried S Delcev Pavle P Kohek Peter P

Frontiers in surgery 20210205

<b>Introduction:</b> The use of negative pressure dressings for open abdominal therapy has made a great impact on strategies for open abdominal treatment. Observed intestinal damage and developement of fistula formation raises questions about safety of commonly used systems (AB-Thera). The most common used system uses foils for shielding intestines directly from negative pressure. As an alternative a system with open pore dressing in double layer film was introduced (Suprasorb CNP) and proved to ...[more]

PMID: 33614699

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Project description:The aim was to assess the appropriateness of recommended regimens for empirical MIC coverage in critically ill patients with open-abdomen and negative-pressure therapy (OA/NPT). Over a 5-year period, every critically ill patient who received amikacin and who underwent therapeutic drug monitoring (TDM) while being treated by OA/NPT was retrospectively included. A population pharmacokinetic (PK) modeling was performed considering the effect of 10 covariates (age, sex, total body weight [TBW], adapted body weight [ABW], body surface area [BSA], modified sepsis-related organ failure assessment [SOFA] score, vasopressor use, creatinine clearance [CLCR], fluid balance, and amount of fluids collected by the NPT over the sampling day) in patients who underwent continuous renal replacement therapy (CRRT) or did not receive CRRT. Monte Carlo simulations were employed to determine the fractional target attainment (FTA) for the PK/pharmacodynamic [PD] targets (maximum concentration of drug [C max]/MIC ratio?of ?8 and a ratio of the area under the concentration-time curve from 0 to 24 h [AUC0-24]/MIC of ?75). Seventy critically ill patients treated by OA/NPT (contributing 179 concentration values) were included. Amikacin PK concentrations were best described by a two-compartment model with linear elimination and proportional residual error, with CLCR and ABW as significant covariates for volume of distribution (V) and CLCR for CL. The reported V) in non-CRRT and CRRT patients was 35.8 and 40.2 liters, respectively. In Monte Carlo simulations, ABW-adjusted doses between 25 and 35?mg/kg were needed to reach an FTA?of >85% for various renal functions. Despite an increased V and a wide interindividual variability, desirable PK/PD targets may be achieved using an ABW-based loading dose of 25 to 30?mg/kg. When less susceptible pathogens are targeted, higher dosing regimens are probably needed in patients with augmented renal clearance (ARC). Further studies are needed to assess the effect of OA/NPT on the PK parameters of antimicrobial agents.

Project description:BackgroundInternational register of open abdomen (IROA) enrolls patients from several centers in American, European, and Asiatic continent. The aim of our study is to compare the characteristics, management and clinical outcome of adult patients treated with OA in the three continents.Material and methodsA prospective analysis of adult patients enrolled in the international register of open abdomen (IROA).Trial registrationNCT02382770.Results1183 patients were enrolled from American, European and Asiatic Continent. Median age was 63 years (IQR 49-74) and was higher in the European continent (65 years, p < 0.001); 57% were male. The main indication for OA was peritonitis (50.6%) followed by trauma (15.4%) and vascular emergency (13.5%) with differences among the continents (p < 0.001). Commercial NPWT was preferred in America and Europe (77.4% and 52.3% of cases) while Barker vacuum pack (48.2%) was the preferred temporary abdominal closure technique in Asia (p < 0.001). Definitive abdominal closure was achieved in 82.3% of cases in America (fascial closure in 90.2% of cases) and in 56.4% of cases in Asia (p < 0.001). Prosthesis were mostly used in Europe (17.3%, p < 0.001). The overall entero-atmospheric fistula rate 2.5%. Median open abdomen duration was 4 days (IQR 2-7). The overall intensive care unit and hospital length-of-stay were, respectively, 8 and 11 days (no differences between continents). The overall morbidity and mortality rates for America, Europe, and Asia were, respectively, 75.8%, 75.3%, 91.8% (p = 0.001) and 31.9%, 51.6%, 56.9% (p < 0.001).ConclusionThere is no uniformity in OA management in the different continents. Heterogeneous adherence to international guidelines application is evident. Different temporary abdominal closure techniques in relation to indications led to different outcomes across the continents. Adherence to guidelines, combined with more consistent data, will ultimately allow to improving knowledge and outcome.

Project description:BackgroundFluid overload (FO) after resuscitation is frequent and contributes to adverse outcomes among postinjury open abdomen (OA) patients. Bioelectrical impedance analysis (BIA) is a promising tool for monitoring fluid status and FO. Therefore, we sought to investigate the efficacy of BIA-directed fluid resuscitation among OA patients.MethodsA pragmatic, prospective, randomized, observer-blind, single-center trial was performed for all trauma patients requiring OA between January 2013 and December 2017 to a national referral center. A total of 140 postinjury OA patients were randomly assigned in a 1:1 ratio to receive either a BIA-directed fluid resuscitation (BIA) protocol that included fluid administration with monitoring of hemodynamic parameters and different degrees of interventions to achieve a negative fluid balance targeting the hydration level (HL) measured by BIA or a traditional fluid resuscitation (TRD) in which clinicians determined the fluid resuscitation regimen according to traditional parameters during 30 days of ICU management. The primary outcome was the 30-day primary fascial closure (PFC) rate. The secondary outcomes included the time to PFC, postoperative 7-day cumulative fluid balance (CFB) and adverse events within 30 days after OA. The Kaplan-Meier method and the log-rank test were utilized for PFC after OA. A generalized linear regression model for the time to PFC and CFB was built.ResultsA total of 134 patients completed the trial (BIA, n = 66; TRD, n = 68). The BIA patients were significantly more likely to achieve PFC than the TRD patients (83.33% vs. 55.88%, P < 0.001). In the BIA group, the time to PFC occurred earlier than that of the TRD group by an average of 3.66 days (P < 0.001). Additionally, the BIA group showed a lower postoperative 7-day CFB by an average of 6632.80 ml (P < 0.001) and fewer complications.ConclusionAmong postinjury OA patients in the ICU, the use of BIA-guided fluid resuscitation resulted in a higher PFC rate and fewer severe complications than the traditional fluid resuscitation strategy.

Dataset Information

Effect of Negative Pressure Therapy on Open Abdomen Treatments. Prospective Randomized Study With Two Commercial Negative Pressure Systems.

Publications

Effect of Negative Pressure Therapy on Open Abdomen Treatments. Prospective Randomized Study With Two Commercial Negative Pressure Systems.

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