Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05966961

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pineta Grande Hospital, Naples, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing an emergency or elective laparotomy or laparoscopic surgery.
  • Written informed consent
  • Age≥ 18 years
  • Not incapacitated patient

Exclusion criteria

  • No exclusion criteria except patients with allergy or hypersensitivity to chlorhexidine

Treatment and study plan

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.

Primary outcomes

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

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

    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).

Secondary outcomes

  1. Handling of the suture material

    Time frame: intraoperatively

    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).

  2. Length of hospital stay

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

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

  3. Time to return to work

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

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

  4. Incidence of Surgical Site Infection (SSI)

    Time frame: at discharge (approximately 10 days after surgery)

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

  5. Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class

    Time frame: until 30 days + 5 days after surgery

    Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class (Class I clean, Class II clean/contaminated, Class III contaminated, Class IV dirty/infected)

  6. Cumulative Rate of postoperative complications

    Time frame: discharge (approximately 10 days after surgery) and 30 days+ 5 days after surgery.

    Number of postoperative complications of any kind for descriptive analysis

  7. Cumulative Rate of reoperation

    Time frame: at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.

    Number of reoperation of any kind for descriptive analysis

  8. Cumulative Rate of suture removal due to wound problems

    Time frame: at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.

    Rate of suture removal due to wound problems (infection, dehiscence, residual material requiring removal) for descriptive analysis

  9. Cumulative Rate of Re-suturing

    Time frame: at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.

    Rate of Re-suturing of any kind for descriptive analysis

  10. Hernia rate

    Time frame: 30 days + 5 days postoperatively

    Number of Wound Hernia including umbilical hernia verified by ultra-sound examination

Study contacts

Contact information is provided by the study sponsor or research team.

Jaume Garcia Lopez

CONTACT

[email protected]

+34935866200

Ricard Rosique

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • B.Braun Surgical SA

Registry information

Official study title

'All Comer'/'Real-world' Registry-based Randomized, Prospective, Multicenter Clinical Trial to Evaluate the Incidence of Complications Using Novosyn® CHD Suture Versus Polyglactin 910 Suture to Close the Wound After Emergency or Elective Laparotomy or Laparoscopic Surgery

Acronym: POLYNOVO-CHD

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Aug 1, 2023
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.