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

Study Overview
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Brief Summary
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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.

Official Title
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'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

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Device: Novosyn® in emergency or elective laparotomy or laparoscopic surgery
* Device: Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Novosyn®<br>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<br>* Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.<br>|
| Polyglactin 910<br>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<br>* Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Novosyn®, Chlorhexidine coated suture, emergency laparoscopic surgery, emergency laparotomy surgery, elective laparoscopic surgery, elective laparotomy surgery, Polyglactin 910