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

'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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgical Site Infection
• Intervention / Treatment: Device: Novosyn® in emergency or elective laparotomy or laparoscopic surgery; Device: Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery

• Study Type: Observational
• Enrollment (Estimated): 2998

Contacts and Locations

• Study Contact: Name: Ricard Rosique; Email: info@bbraun.com
• Study Contact Backup: Name: Jaume Garcia Lopez; Phone Number: +34935866200; Email: info@bbraun.com

Study Locations

• Spain
  • Madrid, Spain
    • Recruiting
    • Hospital Clinico San Carlos
    • Contact: Antonio José Torres Garcia, Dr.
    • Principal Investigator: Antonio José Torres Garcia, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Novosyn®; 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	Device: Novosyn® in emergency or elective laparotomy or laparoscopic surgery; Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.
Polyglactin 910; 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	Device: Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery; Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	until 30 days + 5 days after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	intraoperatively
Length of hospital stay	Number of days the patient has to stay in hospital after emergency or elective laparotomy or laparoscopic surgery	until discharge (approximately 10 days after surgery)
Time to return to work	Number of days the patient needed to return to work after emergency or elective laparotomy or laparoscopic surgery	until 30 days + 5 days after surgery.
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	at discharge (approximately 10 days after surgery)
Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class	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)	until 30 days + 5 days after surgery
Cumulative Rate of postoperative complications	Number of postoperative complications of any kind for descriptive analysis	discharge (approximately 10 days after surgery) and 30 days+ 5 days after surgery.
Cumulative Rate of reoperation	Number of reoperation of any kind for descriptive analysis	at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
Cumulative Rate of suture removal due to wound problems	Rate of suture removal due to wound problems (infection, dehiscence, residual material requiring removal) for descriptive analysis	at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
Cumulative Rate of Re-suturing	Rate of Re-suturing of any kind for descriptive analysis	at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
Hernia rate	Number of Wound Hernia including umbilical hernia verified by ultra-sound examination	30 days + 5 days postoperatively

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA
• Investigators: Principal Investigator: Antonio José Torres Garcia, Prof. Dr., Hospital San Carlos, Madrid

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Polyglactin 910; Chlorhexidine coated suture; emergency laparoscopic surgery; emergency laparotomy surgery; elective laparoscopic surgery; elective laparotomy surgery; Novosyn®
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Disease Attributes; Wound Infection; Emergencies; Surgical Wound Infection
• Other Study ID Numbers: AAG-G-H-2201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No