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A Prospective Randomized Controlled Trial Comparing Clinical Equivalence of PD Synth and PDS Polydioxanone Sutures
Amritha Prabha Shankar1, Stanley Mathew2, V S S Nagababu Tippana3
1Department of Surgical Oncology, Vydehi Institute of Medical Sciences and Research Centre, Bengaluru, IND.
Cureus
|January 11, 2024
Summary
PD Synth and PDS polydioxanone sutures are clinically equivalent for abdominal fascial closure after midline laparotomy, showing similar low rates of incisional hernia and comparable secondary outcomes in a randomized study.
Area of Science:
- Surgical innovation and materials science.
- Clinical trial methodology and patient outcomes.
- Gastrointestinal surgery and hernia prevention.
Background:
- Incisional hernia is a frequent complication following midline laparotomy, impacting patient recovery and quality of life.
- Effective abdominal fascia closure using appropriate suture materials is crucial for reducing incisional hernia incidence.
- Polydioxanone sutures are commonly used for their slow absorption properties in abdominal wall closure.
Purpose of the Study:
- To compare the clinical equivalence of PD Synth and PDS slowly absorbed polydioxanone sutures.
- To evaluate the incidence of incisional hernia following elective/emergency midline laparotomy using these two suture types.
- To assess various secondary endpoints related to surgical site complications and patient recovery.
Main Methods:
- A prospective, multicenter, randomized (1:1), single-blind, two-arm, parallel-group study involving 88 subjects undergoing midline laparotomy.
- Subjects were randomized to receive either PD Synth (n=45) or PDS (n=43) polydioxanone sutures for abdominal fascia closure.
- The primary endpoint was the incidence of incisional hernia at six and 12 months post-surgery, with secondary endpoints including surgical site infections, seroma, and patient satisfaction.
Main Results:
- A comparable low incidence of incisional hernia was observed, with one subject in each group developing a hernia at 12 months (p>0.05).
- Secondary outcomes, including surgical site infection, seroma, and hematoma, were also comparable between the PD Synth and PDS groups.
- No significant differences were noted in operative data, hospital stay, pain, or return to normal activities.
Conclusions:
- PD Synth and PDS slowly absorbed polydioxanone sutures demonstrate clinical equivalence for abdominal fascial closure.
- Both suture types are suitable for use following midline laparotomy, offering comparable safety and efficacy profiles.
- The study supports the interchangeable use of PD Synth and PDS sutures in preventing incisional hernias.
