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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2998 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-18

Study Completion Date

2028-08-31

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.

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Detailed Description

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Conditions

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Surgical Site Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Novosyn® in emergency or elective laparotomy or laparoscopic surgery

Intervention Type DEVICE

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

Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery

Intervention Type DEVICE

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

Interventions

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Novosyn® in emergency or elective laparotomy or laparoscopic surgery

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

Intervention Type 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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No