A Prospective Randomized Controlled Trial Comparing Clinical Equivalence of PD Synth and PDS Polydioxanone Sutures

Abstract

Introduction Incisional hernia is a common complication of midline laparotomy that may develop even after several years of surgery. Abdominal fascia closure with ideal suture material reduces the incidence of incisional hernia. This study compared the clinical equivalence of PD Synth (Healthium Medtech Limited) and PDS (Ethicon, Johnson & Johnson) slowly absorbed polydioxanone suture with respect to the occurrence of incisional hernia, following elective/emergency midline laparotomy. Methods Eighty-eight subjects undergoing elective/emergency midline laparotomy were randomized to PD Synth (n=45) and PDS (n=43) groups of this prospective, multicenter, randomized (1:1), single-blind, two-arm, parallel-group study (December 2020-May 2023). Primary endpoint was incidence of incisional hernia, occurring within six and 12 months of surgery. Secondary endpoints included incidence of fascial dehiscence, surgical site infection (SSI), suture sinus, seroma, hematoma, scar tenderness, and re-suturing, and evaluation of operative data, hospital stay, intra-operative suture handling, pain, time to return to normal day-to-day activities and work, overall patient satisfaction score, and adverse events. Results One subject in both PD Synth and PDS groups (p>0.05) developed incisional hernia at umbilicus 12 months post-laparotomy. In PDS group, one subject each had incidences of SSI on day 2, day 7, and one month, two subjects developed seroma on day seven, and one subject had readmission on one month; two subjects in PD Synth group developed superficial SSI (one month). Findings of other secondary endpoints were comparable between the groups. Conclusion Primary and secondary outcomes manifested that PD Synth and PDS slowly absorbed polydioxanone sutures are clinically equivalent, and can be used for abdominal fascial closure following midline laparotomy.

Keywords: absorbable suture; fascial dehiscence; incisional hernia; midline laparotomy; polydioxanone suture.

Figure 1. CONSORT flow chart of the study.

CONSORT: Consolidated Standards of Reporting Trials n: number of patients

Figure 2. Intra-operative suture handling characteristics in subjects assigned to PD Synth (n=45) and PDS (n=43) groups.

Figure 3. Mean pain score with VAS (a), grade of pain (b), and number of analgesics in subjects assigned to PD Synth (n=45) and PDS (n=43) groups (c).

*P<0.05 is considered significant. VAS: visual analog scale

Figure 4. EuroQoL five-dimensional three-level questionnaire for overall well-being.

*P<0.05 is considered significant. The images show (a) mobility, (b) self-care, (c) usual activities, (d) pain/discomfort, (e) depression/anxiety, and (f) EuroQol-visual analog scale for global assessment of health in subjects assigned to PD Synth (n=45) and PDS (n=43) groups.