POLYNOVO

Description

A multicenter, prospective, randomized clinical trial based on a “real-world” registry to evaluate the incidence of complications following emergency or elective laparoscopy or laparotomy using Novosyn CHD suture versus polyglactin 910 suture for incision closure.

Target

A clinical study is used to gather information about a medical device that is used in routine clinical practice. Polylactide 910 and Novosyn CHD sutures are medical devices that have already been certified and approved.

To whom it is addressed

Women and men who have undergone an emergency or elective laparotomy or laparoscopic surgery.

Treatment

Participants are randomly assigned to one of two suture types: polylactide 910 and Novosyn CHD.

Study phases

Initial Assessment:

A physical examination is performed to confirm that the patient is able to participate.

Treatment:
Surgery was indicated. Discharged.

Follow-up:
Checkups are conducted to assess the progression of the wound infection.

Duration of the study

30 days after surgery.

What is evaluated

• Wound Assessment.
• Safety and side effects.

Possible risks and side effects

Side effects of chlorhexidine reported in rare cases (1 in 1,000 treated) include allergic reactions, contact dermatitis, or anaphylactic shock following contact with chlorhexidine. The concentration of chlorhexidine in the suture is very low, at 60 µg/m of thread, whereas the concentration of chlorhexidine in mouthwashes ranges from 2% to 0.2%.