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

Recruiting

• Conditions: Surgical Site Infection
• Interventions: Device: Novosyn® in emergency or elective laparotomy or laparoscopic surgery; Device: Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery

• Registration Number: NCT05966961
• Lead Sponsor: Aesculap AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-19
• Study First Submitted QC: 2023-07-28
• Study First Posted: 2023-08-01
• Study Start: 2023-09-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03
• Primary Completion: 2028-06
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2998

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Novosyn®	Novosyn® in emergency or elective laparotomy or laparoscopic surgery	Sutures will be used to close the laparotomy or trocar incision in emergency or elective surgery. The suture material will be applied for fascia closure (and subcutaneous closure if applicable) in the context of daily clinical routine
Polyglactin 910	Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery	Sutures will be used to close the laparotomy or trocar incision in emergency or elective surgery. The suture material will be applied for fascia closure (and subcutaneous closure if applicable) in the context of daily clinical routine

Primary Outcome Measures

Name	Time	Method
Frequency of surgical site infection (superficial (A1) and deep (A2)	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 Outcome Measures

Name	Time	Method
Length of hospital stay	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
Handling of the suture material	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).
Incidence of Surgical Site Infection (SSI)	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
Cumulative Rate of Re-suturing	at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.	Rate of Re-suturing of any kind for descriptive analysis
Cumulative Rate of reoperation	at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.	Number of reoperation of any kind for descriptive analysis
Time to return to work	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
Cumulative Rate of suture removal due to wound problems	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
Hernia rate	30 days + 5 days postoperatively	Number of Wound Hernia including umbilical hernia verified by ultra-sound examination
Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class	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)
Cumulative Rate of postoperative complications	discharge (approximately 10 days after surgery) and 30 days+ 5 days after surgery.	Number of postoperative complications of any kind for descriptive analysis

Trial Locations

Locations (4)

Pineta Grande Hospital; 🇮🇹 Napoli, Italy

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Universitario de Canarias; 🇪🇸 Sta. Cruz de Tenerife, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain