Clinical trial NCT05966961: Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgical Site Infection
Keywords: Chlorhexidine coated suture
emergency laparoscopic surgery
emergency laparotomy surgery
elective laparoscopic surgery
elective laparotomy surgery
Novosyn®
Polyglactin 910
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2023-08-01
Enrollment: 2998
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing wound closure after emergency or elective laparoscopic or laparotomy surgery

Brief summary: 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: 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

Primary outcomes:
measure: Frequency of surgical site infection (superficial (A1) and deep (A2)
timeFrame: until 30 days + 5 days after surgery.
Secondary outcomes:
measure: Handling of the suture material
timeFrame: intraoperatively
measure: Length of hospital stay
timeFrame: until discharge (approximately 10 days after surgery)
measure: Time to return to work
timeFrame: until 30 days + 5 days after surgery.
measure: Incidence of Surgical Site Infection (SSI)
timeFrame: at discharge (approximately 10 days after surgery)
measure: Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class
timeFrame: until 30 days + 5 days after surgery
measure: Cumulative Rate of postoperative complications
timeFrame: discharge (approximately 10 days after surgery) and 30 days+ 5 days after surgery.
measure: Cumulative Rate of reoperation
timeFrame: at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
measure: Cumulative Rate of suture removal due to wound problems
timeFrame: at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
measure: Cumulative Rate of Re-suturing
timeFrame: at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
measure: Hernia rate
timeFrame: 30 days + 5 days postoperatively
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Pineta Grande Hospital
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Sta. Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias
Study officials:
affiliation: Hospital San Carlos, Madrid
name: Antonio José Torres Garcia, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: