Feasibility and safety of 4DryField^® PH as a hemostatic agent in ovarian surgery on fertility: a pilot randomized...

To evaluate the feasibility and safety of the hemostatic powder 4DryField® PH in laparoscopic ovarian cystectomy and its impact on fertility compared to conventional bipolar electrocautery.

This is a prospective, randomized, controlled, single-center, single-blind pilot study, included in the german registry for clinical trials (DRKS-ID: DRKS00038742). The study was developed in the. Department of Gynecology and Gynecological Oncology, University Hospital Bonn, Germany. Twenty women (≥ 18 years old) undergoing laparoscopic ovarian cystectomy for benign ovarian lesions with baseline serum anti-Müllerian hormone (AMH) ≥ 2.0 ng/mL were enrolled and randomized equally to two hemostatic methods. Hemostasis was achieved using either bipolar electrocautery (n = 10) or topical 4DryField® PH powder (n = 10). Both groups underwent standardized laparoscopic cystectomy performed by experienced surgeons. Serum AMH, C-reactive protein (CRP), interleukin-6 (IL-6), procalcitonin (PCT), white blood cell counts, hemoglobin and hematocrit were assessed preoperatively, on postoperative day (POD) 1, and POD 14.

Baseline AMH levels were comparable between groups (4.54 ± 2.24 ng/mL vs. 4.39 ± 2.08 ng/mL, p = 0.85). By POD 14, the mean percent decline in AMH from baseline was smaller in the 4DryField group than in the electrocautery group (mean difference = 16.77%; 95% CI: -5.39 to 38.93). This difference was not statistically significant (p = 0.36), with an estimated effect size of d= 0.72 (95% CI: -0.19 to 1.62). IL-6 increased transiently on POD 1 in the 4DryField group (9.2 pg/mL [IQR 78.6] vs. 3.85 pg/mL [IQR 2.80]; p = 0.016) but normalized by POD 14, indicating a short, non-pathologic inflammatory response. No significant differences were observed in CRP, PCT, or leukocyte counts. No adverse events, infections, or hemorrhagic complications occurred in either group.

In this pilot study, the use of 4DryField® PH appears feasible and safe for laparoscopic ovarian cystectomy. While the reduction in AMH levels was numerically smaller in the 4DryField group, the difference was not statistically significant. These results are hypothesis-generating and underscore the need for larger trials to evaluate the potential benefits of non-thermal hemostatic strategies for ovarian reserve preservation.

Clinical trial; DRKS00038742.