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

Sponsor

Aesculap AG (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05966961

Collaborator

B.Braun Surgical SA (Industry)

2,998

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infection	Device: Novosyn® in emergency or elective laparotomy or laparoscopic surgery Device: Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2998 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2028

Anticipated Study Completion Date :

Aug 1, 2028

Arms and Interventions

Arm	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.

Arm

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

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.

Outcome Measures

Primary Outcome Measures

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

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).
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
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
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
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
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
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
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
Hernia rate [30 days + 5 days postoperatively]
Number of Wound Hernia including umbilical hernia verified by ultra-sound examination