Within-patient randomized clinical trial comparing incisional negative-pressure wound therapy with suction drains in gender-affirming mastectomies.

BACKGROUND: Incisional negative-pressure wound therapy (iNPWT) is widely adopted by different disciplines for multiple indications. Questions about the most appropriate uses and value of iNPWT have been raised. METHODS: An open-label within-patient RCT was conducted in transgender men undergoing gender-affirming mastectomies. The objective was to determine the effect of iNPWT as a substitute for standard dressing and suction drains on wound healing complications. One chest side was randomized to receive the iNPWT intervention, and the other to standard dressing with suction drain. The primary endpoints were wound healing complications (haematoma, seroma, infection, and dehiscence) after three months. Additional outcomes were pain according to a numerical rating scale and patient satisfaction one week after surgery. RESULTS: Eighty-five patients were included, of whom 81 received both the iNPWT and standard treatment. Drain removal criteria were met within 24 h in 95 per cent of the patients. No significant decrease in wound healing complications was registered on the iNPWT side, but the seroma rate was significantly increased. In contrast, patients experienced both significantly less pain and increased comfort on the iNPWT side. No medical device-related adverse events were registered. CONCLUSION: Substituting short-term suction drains with iNPWT in gender-affirming mastectomies increased the seroma rates and did not decrease the amount of wound healing complications. Registration number: NTR7412 (Netherlands Trial Register).

Restoration of bowel continuity after surgery for acute perforated diverticulitis: should Hartmann's procedure be considered a one-stage procedure?

OBJECTIVE: Hartmann's procedure (HP) still remains the most frequently performed procedure in acute perforated diverticulitis, but it results in a end colostomy. Primary anastomosis (PA) with or without defunctioning loop ileostomy (DI) seems a good alternative. The aim of this study was to assess differences in the rate of stomal reversal after HP and PA with DI and to evaluate factors associated with postreversal morbidity in patients operated for acute perforated diverticulitis. METHOD: All 158 patients who had survived emergency surgery for acute perforated diverticulitis in five teaching hospitals in The Netherlands between 1995 and 2005 and underwent HP or PA with DI were retrospectively studied. Age, gender, ASA-classification, severity of primary disease, delay of stoma reversal, surgeon's experience, surgical procedure and type of anastomosis were analysed in relation to outcome after stoma reversal. RESULTS: Of the 158 patients, 139 had undergone HP and 19 PA with DI. The reversal-rate was higher in patients with DI (14/19; 74%) compared to HP (63/139; 45%) (P = 0.027) Delay between primary surgery and stoma reversal was shorter after PA with DI compared with HP (3.9 vs 9.1 months; P < 0.001). Cumulative postreversal morbidity after HP was 44%. Early surgical complications occurred in 22 of 63 patients. Morbidity after DI reversal was 15% (P < 0.001). Three patients died after HP reversal, none died after DI reversal. Anastomotic leakage was observed in 10 patients after HP reversal. This was less frequently observed when the operation was performed by a specialist colorectal surgeon (10%vs 33%; P = 0.049) and when a stapled anastomosis was performed (4%vs 24%; P = 0.037). CONCLUSIONS: Reversal of HP should only be performed by an experienced colorectal surgeon, preferably performing a stapled anastomosis, or probably not be performed at all, as it is accompanied by high postoperative morbidity and even mortality. It is important that these findings are taken in account for when performing primary emergency surgery for acute perforated diverticulitis.

Influence of systolic-pressure-variation-guided intraoperative fluid management on organ function and oxygen transport.

BACKGROUND: Dynamic variables, for example, systolic pressure variation (SPV), are superior to filling pressures for assessing fluid responsiveness. We analysed the effects of SPV-guided intraoperative fluid management on organ function and perfusion when compared with routine care. METHODS: Eighty patients (44 female and 36 male) undergoing elective major abdominal surgery were randomly assigned to a control group [n=40, mean age 66 (sd 10), range 40-84 yr] or SPV group [n=40, age 61 (16), range 26-100 yr] in which intraoperative fluid management was guided by SPV (trigger: SPV>10%). Central venous O2 saturation (ScvO2), lactate and bilirubin, creatinine, indocyanine green plasma disappearance rate (ICG-PDR), and gastric mucosal CO(2) tension were measured after induction of anaesthesia, after 3, 6, 12, and 24 h. RESULTS: Patient characteristics, duration of surgery [5.8 (2.5) vs 5.4 (2.5) h], and infusion volumes (median 4865 vs 4330 ml) were comparable between the groups. At 3 and 6 h, SPV (P=0.04, P=0.01) and Deltadown (P=0.005, P=0.01) were significantly higher in the control group. Oxygen transport and organ function were comparable: baseline and 24 h values for ICG-PDR: 28.5 (7.9) and 22.7 (7.8) vs 23.9 (6.9) and 26.1 (5.9)% min(-1), 77.7 (6.6) and 72.6 (5.5) vs 79.3 (7.1) and 72.8 (6.7)% for ScvO2 and 1.0 (0.4) and 1.2 (0.6) vs 0.9 (0.2) and 1.3 (0.5) mmol litre(-1) for lactate. Length of mechanical ventilation, ICU stay, and mortality were comparable. CONCLUSIONS: In comparison with routine care, intraoperative SPV-guided treatment was associated with slightly increased fluid adminstration whereas organ perfusion and function was similar.

Measurement of cardiac output: a comparison between transpulmonary thermodilution and uncalibrated pulse contour analysis.

BACKGROUND: Recently, continuous monitoring of cardiac output (CO) based on pulse contour analysis (Vigileo) has been introduced into practice. In this clinical study, we evaluated the accuracy of this system by comparing it with the transpulmonary thermodilution technique (TPID) in septic patients. METHODS: We studied 24 mechanically ventilated patients with septic shock (16 male, 8 female, age 26-77 yr) receiving treatment with norepinephrine who for clinical indication underwent haemodynamic monitoring by the transpulmonary thermodilution technique using a PiCCO plus system (Pulsion Medical Systems, Munich, Germany). In parallel, arterial pulse contour was applied using the femoral arterial pressure curve (FloTrac pressure sensor, Vigileo monitor, Edwards Lifesciences, Irvine, USA). After baseline measurement, mean arterial pressure was elevated by increasing norepinephrine dosage, and CO was measured again before mean arterial pressure was reduced back to baseline levels. Fluid status and ventilator settings remained unchanged throughout. At each time point, CO by transpulmonary thermodilution was calculated from three central venous bolus injections of 15 ml of saline (<8 degrees C). Linear regression and the Bland-Altman method were used for statistical analysis. RESULTS: Overall, CO was 6.7 (sd 1.8) (3.2-10.1) litre min(-1) for CO(TPID) and 6.2 (2.4) (3.0-17.6) litre min(-1) for CO(Vigileo((R))). Linear regression revealed: CO(Vigileo) = 1.54 + 0.72 x CO(TPID) litre min(-1), r(2) = 0.26 (P < 0.0001). Mean bias between techniques [CO(TPID)-CO(Vigileo)] was 0.5 litre min(-1) (SD 2.3 litre min(-1)). Correlation coefficients at the three time points were not significantly different from each other. CONCLUSIONS: Pulse contour analysis-derived CO (Vigileo system) underestimates CO(TPID) and is not as reliable as transpulmonary thermodilution in septic patients.

Positive end-expiratory pressure does not affect indocyanine green plasma disappearance rate or gastric mucosal perfusion after cardiac surgery.

BACKGROUND AND OBJECTIVE: Positive end-expiratory pressure (PEEP) may affect hepato-splanchnic blood flow. We studied whether a PEEP of 10 mbar may negatively influence flow-dependent liver function (indocyanine green plasma disappearance rate, ICG-PDR) and splanchnic microcirculation as estimated by gastric mucosal PCO2 (PRCO2). METHODS: In a randomized, controlled clinical study, we enrolled 28 patients after elective cardiac surgery using cardiopulmonary bypass. In 14 patients (13 male, 1 female; age 48-74, mean 63 +/- 7 yr) we assessed ICG-PDR and PRCO2 on intensive care unit admission with PEEP 5 mbar, after 2 h with PEEP of 10 mbar and again after 2 h at PEEP 5 mbar. Inspiratory peak pressure was adjusted to maintain normocapnia. Fourteen other patients (8 male, 6 female; age 46-86, mean 68 +/- 11 yr) in whom PEEP was 5 mbar throughout served as controls. All patients underwent haemodynamic monitoring by measurement of central venous pressure, left atrial pressure and cardiac index using pulmonary artery thermodilution. RESULTS: While doses of vasoactive drugs and cardiac filling pressures did not change significantly, cardiac index slightly increased in both groups. ICG-PDR remained unchanged either within or between both groups (PEEP10 group: 24.0 +/- 6.9, 22.0 +/- 7.9 and 25.5 +/- 7.7% min-1 vs. controls: 22.0 +/- 7.5, 23.8 +/- 8.4 and 21.4 +/- 6.5% min-1) (P = 0.05). The difference between PRCO2 and end-tidal PCO2 (PCO2-gap) did not change significantly (PEEP10 group: 1.1 +/- 0.9, 1.3 +/- 0.7 and 1.3 +/- 0.9 kPa vs. controls: 0.8 +/- 0.5, 0.9 +/- 0.5 and 0.9 +/- 0.5 kPa). CONCLUSION: A PEEP of 10 mbar for 2 h does not compromise liver function and gastric mucosal perfusion in patients after cardiac surgery with maintained cardiac output.

Increasing cardiac output by fluid loading: effects on indocyanine green plasma disappearance rate and splanchnic microcirculation.

BACKGROUND: Sufficient cardiac pre-load for maintaining adequate cardiac output is a major goal in the treatment of critically ill patients. We studied the effects of increasing cardiac output by fluid loading on the indocyanine green plasma disappearance rate (ICG-PDR) and gastric mucosal regional CO2 tension (PRco2) as an indicator of splanchnic microcirculation. METHODS: With approval by our ethics committee and written consent, we studied post-operatively 12 patients (1 female, 11 males; 66 +/- 13 years) with elective coronary artery bypass grafting (n = 10) or aortic valve replacement (n = 2). All patients had received pulmonary artery and left atrial catheterization previously for clinical indications. Cardiac output and filling pressures were measured immediately after intensive care unit (ICU) admission and 1 h after the beginning of fluid loading. RESULTS: Overall, 630 +/- 130 ml of 6% hydroxyethylstarch (130 kDa) was infused with the splanchnic perfusion pressure remaining constant. Norepinephrine and epinephrine dosages were unchanged. The cardiac index increased significantly from 2.8 +/- 0.7 to 3.5 +/- 0.6 l/min/m2 and the stroke volume index from 30 +/- 7 to 38 +/- 8 ml/m2. ICG-PDR showed no significant change, i.e. from 21.2 +/- 6.5 to 21.6 +/- 6.5%/min. Gastric mucosal PRco2 and the Pco2 gap (difference between regional and end-tidal CO2 tension) were constant, i.e. changed from 5.1 +/- 0.8 to 5.5 +/- 1.1 kPa and from 0.9 +/- 0.5 to 1.0 +/- 0.7 kPa, respectively. CONCLUSION: Increasing cardiac output to supranormal values by fluid loading is not associated with a significant change in ICG-PDR or gastric mucosal PRco2.