Effect of 4DryField® PH on blood loss in hip bipolar hemiarthroplasty following intracapsular femoral neck fracture – a randomized clinical trial

Abstract

Background One of the most common complications of hip arthroplasty is excessive blood loss that could necessitate allogenic blood transfusion, which is further associated with other complications, such as infections, transfusion reactions or immunomodulation. In gynecology, 4DryField®PH, an absorbable polysaccharide-based formulation, is used for hemostasis and adhesion prophylaxis. In this study, we evaluated its hemostatic effect in patients undergoing hip bipolar hemiarthroplasty following intracapsular femoral neck fracture. Methods We studied 40 patients with intracapsular femoral neck fractures (Garden III or IV) admitted at our institution between July 2016 and November 2017. We included patients above 60 years with simple fracture and without pathologic fractures. Patients were randomized into intervention and control groups. The intervention group received 5 g of 4DryField® PH (subfascially and subcutaneously) during wound closure. Three drainages were inserted in a standardized manner (submuscular, subfascial, and subcutaneous) and drainage volume was measured immediately before extraction. Total blood loss was calculated using Mercuriali’s formula and standard hemograms upon admission and five days after surgery. Volume of postoperative hematoma was measured using point-of-care ultrasound seven days after surgery. Results Volume of the postoperative hematoma was reduced by 43.0 mL. However, significant reduction of total blood loss and drainage volume was not observed. Conclusions We observed that 4DryField® PH had a local hemostatic effect, thereby reducing volume of the postoperative hematoma. However, this reduction was small and had no effect on the total blood loss. Further studies are warranted to improve the application algorithm. Trial registration DRKS, DRKS00017452, Registered 11 June 2019 – Retrospectively registered.

Significant adhesion reduction and time saving in pediatric heart surgery with 4DryField PH: A retrospective, controlled study

“…Equally positive is the tolerability and safety of 4DryField ® . Each patient, regardless of body weight, had received 5 g of product, which corresponds to a dose of up to 2 g per kg body weight and thus a much higher dose than ever reported for adults [ 19 – 25 , 31 – 33 ]. Complications did not occur.…”

Comparison of the effect of two anti-adhesion materials on the formation of postoperative adhesions after myomectomy – an experimental study on rabbit does

“…The studies also evaluated in vitro cytotoxicity/biocompatibility as well as in vivo tolerability of the new polysaccharide 4DryField ® PH, which was rated as excellent (Poehnert et al 2015). Several studies using this preparation have been conducted in clinical medicine (Rudolph et al 2019;Lucas et al 2021). In the field of gynaecology, the antiadhesive effect of 4DryField ® PH was evaluated in a clinical trial.…”