Novosyn® CHD vs Polyglactin 910 Sutur til at lukke sår efter nødsituation eller elektiv laparotomi eller laparoskopisk kirurgi (POLYNOVO-CHD)
'All Comer'/'Real-world' Registry-baseret randomiseret, prospektivt, multicenter klinisk forsøg til evaluering af forekomsten af komplikationer ved brug af Novosyn® CHD-sutur versus polyglactin 910-sutur til at lukke såret efter nødsituation eller elektiv laparotomi eller laparoskopisk kirurgi
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Jaume Garcia Lopez
- Telefonnummer: +34935866200
- E-mail: info@bbraun.com
Undersøgelse Kontakt Backup
- Navn: Anna Ibañez Jimenez, Dr.
- E-mail: studies@aesculap.de
Studiesteder
-
-
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Naples, Italien
- Rekruttering
- Pineta Grande Hospital
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Kontakt:
- Francesco Stanzione, Dr.
-
-
-
-
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Santa Cruz de Tenerife, Spanien
- Rekruttering
- Hospital Universitario de Canarias
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Kontakt:
- Javier River Castellano, Dr.
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Seville, Spanien
- Rekruttering
- Hospital Universitario Virgen del Rocío
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Kontakt:
- Javier Pardillo Ruiz, Dr.
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Madrid
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Madrid, Madrid, Spanien
- Rekruttering
- Hospital Clínico San Carlos
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Kontakt:
- Antonio José Torres Garcia, Dr.
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Ledende efterforsker:
- Antonio José Torres Garcia, Dr.
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Patients undergoing wound closure after emergency or elective laparoscopic or laparotomy surgery
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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 |
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 |
Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Frequency of surgical site infection (superficial (A1) and deep (A2)
Tidsramme: 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). |
until 30 days + 5 days after surgery.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Handling of the suture material
Tidsramme: 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). |
intraoperatively
|
|
Length of hospital stay
Tidsramme: 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 |
until discharge (approximately 10 days after surgery)
|
|
Time to return to work
Tidsramme: 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 |
until 30 days + 5 days after surgery.
|
|
Incidence of Surgical Site Infection (SSI)
Tidsramme: 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 |
at discharge (approximately 10 days after surgery)
|
|
Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class
Tidsramme: 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) |
until 30 days + 5 days after surgery
|
|
Cumulative Rate of postoperative complications
Tidsramme: discharge (approximately 10 days after surgery) and 30 days+ 5 days after surgery.
|
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
Tidsramme: at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
|
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
Tidsramme: 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 |
at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
|
|
Cumulative Rate of Re-suturing
Tidsramme: at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
|
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
Tidsramme: 30 days + 5 days postoperatively
|
Number of Wound Hernia including umbilical hernia verified by ultra-sound examination |
30 days + 5 days postoperatively
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Antonio José Torres Garcia, Prof. Dr., Hospital San Carlos, Madrid
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Postoperative komplikationer
- Patologiske processer
- Infektioner
- Sårinfektion
- Patologiske tilstande, tegn og symptomer
- Kirurgisk sårinfektion
- Diagnostiske teknikker og procedurer
- Diagnose
- Kirurgiske procedurer, operative
- Minimalt invasive kirurgiske procedurer
- Diagnostiske teknikker, kirurgisk
- Endoskopi
- Laparoskopi
Andre undersøgelses-id-numre
- AAG-G-H-2201
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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