We found that the use of 4DryField® PH was associated with reduced volume of postoperative hematoma in patients of hip bipolar hemiarthroplasty following intracapsular femoral neck fracture. However, its effect on total blood loss and total drainage volume was not remarkable. Since the difference in total blood loss between the intervention and control group was much less than what we expected, we decided to stop the trial.
Total blood loss in hip arthroplasty includes blood loss intra- and postoperatively. Several strategies have been used to minimize blood loss and to avoid blood transfusion, which may cause adverse effects, such as infection and transfusion reactions [
1,
3]. In this regard, pre- and postoperative administration of tranexamic acid has been effective [
13‐
15]. However, its use is contraindicated in patients with a history of thromboembolism, and is associated with adverse events, such as allergies [
16]. In cases of arthroplasty, tranexamic acid does not significantly increase the rate of deep venous thrombosis or pulmonary embolism. [
4,
15,
17]. However, there is uncertainty regarding the effect of tranexamic acid on the incidence of thromboembolism in case of surgical bleeding [
17,
18]. For this reason, evaluation of alternative agents is necessary. Another possible way of reducing blood loss is through the use of hypotensive epidural anesthesia [
19]. Although this could reduce blood loss as well as rate of blood transfusion, hypotensive epidural anesthesia is contraindicated in patients with severe stenosis of the aortic or mitral valve, severe stenosis of the carotid or vertebral artery, and heart block [
19,
20]. Furthermore, the use of cell salvage techniques could reduce both blood loss and the requirement for blood transfusion with low rates of adverse effects [
19,
21]. However, the high cost of cell salvage techniques may limit their use [
19,
21]. In addition to these methodologies, we used an agent administered topically with a low rate of adverse effects and contraindications. To the best of our knowledge, this study is one of the first to investigate the effect of the polysaccharide 4DryField
® PH on blood loss after hip bipolar hemiarthroplasty. Since 4DryField® PH was administered only during wound closure, we expected to observe a relatively less significant effect on the intraoperative blood loss and a greater effect on the postoperative blood loss. We observed an immediate hemostatic effect of 4DryField® PH after local application, similar to the findings described by Korell et al.. [
6,
22]. In addition, we were also able to show that the volume of postoperative hematoma was significantly reduced with the use of 4DryField® PH.
The total blood loss after surgery was calculated using Mercuriali’s formula [
8,
9], based on the patient’s blood volume calculated using the Nadler formula [
9,
10], which is advantageous since administered blood transfusions are taken into account. Therefore, direct comparison of the blood loss between patients receiving and those not receiving a blood transfusion was possible. We found that 4DryField® PH had no effect on total blood loss and drainage volume. On the other hand, a significant reduction on the volume of the postoperative hematoma was seen in the intervention group (an absolute reduction of 43.00 mL). Moreover, two patients of the control group needed surgical revision because of a large postoperative hematoma. Thus, the finding that total blood loss was unaffected can be explained by the fact that the reduction of hematoma size was relatively small in terms of volume, with the drainage volume being comparable between the two groups.
Limitations
This study did not examine the effects of other factors, such as concurrent medications like anticoagulants, due to the small sample size. The findings of this pilot study are intended to serve as a basis for larger, future studies to generate evidence regarding various aspects of 4DryField® PH, including drug interactions with other medications, parallel use with tranexamic acid, and effects on arthroplasty outcomes. Moreover, the sample size was low according to the intended function as a pilot study. The effects evaluated in this study should be proven using a larger and multi-centric study protocol. Here, the larger applicator content of 9 g should also be investigated. In contrast to most studies, we used 3 redon drainages. Corresponding to our clinical standard, each compartment (submuscular, subfascial, and subcutaneous) was addressed by its own drainage. To fit the literature standard, we summed up the drainage volume, which could result in a bias.
Although the absolute frequencies of the anticoagulative agents were comparable, low-molecular-weight and unfractionated heparin were used, which could cause a bias.
The usage of the polysaccharide 4DryField
® PH was described in literature only in cases of gynecology, visceral surgery, and in body-contouring surgery [
23‐
25]. To the best of our knowledge there are no literature describing its usage in other disciplines, particularly in musculoskeletal surgery. Therefore, a comparison of our results to the literature findings is limited.