Wound Drainage With or Without Blood Salvage? An Open, Prospective, Randomized and Single-Center Comparison of Blood Loss, Postoperative Hemoglobin Levels and Allogeneic Blood Transfusions After Major Hip Surgery

Robert Slappendel, MD, PhD; Wieger Horstmann, MD; Ris Dirksen, MD, PhD; Gijs G. Van Hellemondt, MD

Disclosures

Transfusion Alter Transfusion Med. 2008;10(4):174-181. 

In This Article

Results

Of the 200 patients included, 102 were randomized to the Bellovac ABT and 98 to the Medinorm AG drainage system. The Bellovac ABT drain was used by mistake in one of the patients randomized to receive the Medinorm drain. This patient and two other patients included by mistake, who were younger (36 and 39 years) than the required 45 years of age, and non-major procedures not exceeding 60 minutes were not included in the efficacy analysis. Accordingly, a total of 179 patients, 91 in the Bellovac ABT group and 88 in the Medinorm group, were evaluated for efficacy. All patients were included in the safety evaluation.

Age, sex, duration of surgery and length of hospital stay were similarly distributed between the groups, i.e. no statistically significant differences could be determined. The mean age was 68 (47-89) in the Bellovac ABT group and 69 (45-90) in the Medinorm group. About 60% of the patients included were women. The mean duration of surgery was 108 minutes in the Bellovac ABT group and 111 minutes in the Medinorm group with a range of 60-255 or 258 minutes, respectively. The mean length of the hospital stay was 13 days in both groups (range 5-45 and 5-48 days, respectively; Table 1).

Efficacy

Blood loss was similar in the two treatment groups, and no statistically significant differences could be confirmed (Table 2). Mean blood loss 24 hours after surgery was 566 mL in the Bellovac ABT group and 563 mL in the Medinorm group (range 0-2170 and 5-1980 mL, respectively). The transfusion rate of allogeneic blood within 72 hours postoperatively was 16% in the Medinorm group and 10% in the Bellovac ABT group (Table 3). No further allogeneic transfusions were given until discharge. The randomization resulted in similar distribution of transfusion of intraoperative cell salvage and return of predonated blood. In the Bellovac ABT group eight patients were given a mean volume of 451 mL intraoperatively collected and washed blood, and in the Medinorm group five patients received a mean volume of 705 mL intraoperatively collected and washed blood (P = 0.6216). In both groups, 17 patients were given their predonated blood during the first 24 hours after surgery. The mean volume in the Bellovac ABT group was 486 mL and in the Medinorm group, 413 mL (P = 0.3223). The majority of the patients randomized to the Bellovac ABT group were given postoperative autologous filtered blood from the system, i.e. a total of 60 patients received a mean volume of 374 mL.

The hemoglobin concentration was recorded throughout the hospital stay. The hemoglobin decrease during the first postoperative day was significantly less in the Bellovac ABT group (P = 0.0111), measuring a value of 10.6 g/dL in the Bellovac ABT group and 10.3 g/dL (P = 0.0537) in the Medinorm group at day 1. Preoperative hemoglobin concentration was slightly higher in the Bellovac ABT group, but no statistically significant difference could be determined (P = 0.5461). After day 1, the postoperative hemoglobin values were slightly, although not statistically significantly, higher in the Bellovac ABT group. The same pattern was seen when the change between the preoperative and postoperative values was compared between the groups (Figure 1 and Table 4). Hemoglobin at the day of discharge was obtained in most patients; however, time after surgery for this measurement varied a great deal as the length of the hospital stay varied from 5 to 59 days.

Figure 1.

Mean and 95% confidence interval (CI) of postoperative hemoglobin concentration per treatment group.

Safety

Adverse events were collected and registered throughout the hospital stay. Most adverse events were equally frequent in the two groups, although there were a few exceptions. Wound leakage was more common in the Bellovac ABT group while edema was more common in the Medinorm group. Shivering was registered in four patients, all in the Bellovac ABT group. In one of these four patients, the blood salvaged with the Bellovac ABT drain was never returned. Adverse events are specified in Table 5.

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