RecruitingNCT05966961

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

'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


Sponsor

Aesculap AG

Enrollment

2,998 participants

Start Date

Sep 18, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Patients undergoing an emergency or elective laparotomy or laparoscopic surgery.
  • Written informed consent
  • Age≥ 18 years
  • Not incapacitated patient

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Interventions

DEVICENovosyn® in emergency or elective laparotomy or laparoscopic surgery

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

DEVICEPolyglactin 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(4)

Pineta Grande Hospital

Naples, Italy

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

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NCT05966961


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