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

Surgical Site Infection Clinical Trial

— POLYNOVO-CHD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05966961
• Other study ID #: AAG-G-H-2201
• Status: Recruiting
• Start date: September 18, 2023
• Est. completion date: August 2028

Study information

• Verified date: September 2023
• Source: Aesculap AG
• Contact: Jaume Garcia Lopez
• Phone: +34935866200
• Email: info[@]bbraun.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2998
• Est. completion date: August 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clínico San Carlos	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	B.Braun Surgical SA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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.
Secondary	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)
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Hernia rate	Number of Wound Hernia including umbilical hernia verified by ultra-sound examination	30 days + 5 days postoperatively