Health TrialsbyHealthPanel

Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery

ConditionSurgical Site Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAesculap AG

About this trial

The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1 and A2). The results of this registry will generate further clinical evidence for the use and the benefit of a Chlorhexidine coated suture used to close the wound after an emergency or elective laparoscopic or laparotomy surgery. The benefit for individual patients lies in the early diagnosis of complications and in the optimized postoperative controls of a clinical study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing an emergency or elective laparotomy or laparoscopic surgery.

Written informed consent

Age≥ 18 years

Not incapacitated patient

Disqualifiers

No exclusion criteria except patients with allergy or hypersensitivity to chlorhexidine

Trial population

Patients undergoing wound closure after emergency or elective laparoscopic or laparotomy surgery

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Novosyn® in emergency or elective laparotomy or laparoscopic surgery

    Device

    Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.

  • Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery

    Device

    Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.

Treatment groups

2,998 Participants
are divided into 2 treatment groups
Group A: Novosyn®1 intervention
Group B: Polyglactin 9101 intervention

Trial outcomes

Primary outcomes

1

Frequency of surgical site infection (superficial (A1) and deep (A2)

The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1 and A2).

Time frame
until 30 days + 5 days after surgery.

Secondary outcomes

1

Handling of the suture material

Assessment of the handling of the suture material intraoperatively using a questionnaire including different dimensions (knot security, tensile strength, knot run down, tissue drag etc.) with 5 evaluations levels (excellent, very good, good, satisfied, poor).

Time frame
intraoperatively
2

Length of hospital stay

Number of days the patient has to stay in hospital after emergency or elective laparotomy or laparoscopic surgery

Time frame
until discharge (approximately 10 days after surgery)
3

Time to return to work

Number of days the patient needed to return to work after emergency or elective laparotomy or laparoscopic surgery

Time frame
until 30 days + 5 days after surgery.
4

Incidence of Surgical Site Infection (SSI)

Incidence of Surgical Site Infection (SSI) (superficial (A1), deep (A2) and organ space (A3)) at the time of discharge

Time frame
at discharge (approximately 10 days after surgery)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aesculap AG

Lead sponsor

B.Braun Surgical SA

Collaborator

Source ClinicalTrials.gov
Apply now