NCT05966961

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,998

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Sep 2023Dec 2028

First Submitted

Initial submission to the registry

July 19, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 18, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

4.9 years

First QC Date

July 19, 2023

Last Update Submit

March 5, 2026

Conditions

Surgical Site Infection

Keywords

Chlorhexidine coated sutureemergency laparoscopic surgeryemergency laparotomy surgeryelective laparoscopic surgeryelective laparotomy surgeryNovosyn®Polyglactin 910

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Handling of the suture material

    intraoperatively

  • Length of hospital stay

    until discharge (approximately 10 days after surgery)

  • Time to return to work

    until 30 days + 5 days after surgery.

  • Incidence of Surgical Site Infection (SSI)

    at discharge (approximately 10 days after surgery)

  • Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class

    until 30 days + 5 days after surgery

  • +5 more secondary outcomes

Study Arms (2)

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

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

Interventions

Novosyn® in emergency or elective laparotomy or laparoscopic surgeryDEVICE

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

Novosyn®
Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgeryDEVICE

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

Polyglactin 910

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing wound closure after emergency or elective laparoscopic or laparotomy surgery

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pineta Grande Hospital

Naples, Italy

RECRUITING

Hospital Clínico San Carlos

Madrid, Spain

RECRUITING

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, Spain

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Antonio José Torres Garcia, Prof. Dr.

    Hospital San Carlos, Madrid

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaume Garcia Lopez

CONTACT

+34935866200info@bbraun.com

Ricard Rosique

CONTACT

info@bbraun.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2023

First Posted

August 1, 2023

Study Start

September 18, 2023

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)IT(1)