Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery
Despite adequate antimicrobial prophylaxis and perioperative correction of risk factors, surgical site infections (SSI) remain the most frequent complication of colorectal resection (range 10-17%). Several strategies may be implemented to prevent SSI. Among these, the use of local antimicrobial agents seems successful.
The primary aim of the present trial was to evaluate the efficacy of a surgical suture, coated with Triclosan a synthetic soluble antimicrobial agent, in reducing the SSI rate after colorectal operations.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This was a non-sponsored, multicenter, prospective, randomized, controlled, single-blind study. Two hundred and seventy-three patients candidate to colorectal resection were enrolled. Exclusion criteria were: age < 18 or > 85 years, pregnancy, peritonitis, peritoneal contamination during operation, ongoing infections, ASA score > 3, denied consent.
135 were randomized to the treatment arm and 136 to the control arm. Treatment consisted of abdominal wound closure by suturing peritoneum, fascia, subcutaneous tissue, and skin with Polyglactin 910 Triclosan-coated suture (treatment arm) or with Polyglactin without Triclosan (control arm). SSI were defined according to the Atlanta CDC. Patients were followed up by office visits for 30 days after discharge.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
-
Monza, Italien, 20900
- San Gerardo Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- patients candidate to elective colorectal resection
Exclusion Criteria:
- no consent
- peritonitis
- hypersensitivity to triclosan
- ASA > 3
- ongoing infections
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: control
regular suture not coated with triclosan
|
The control arm will have the abdominal wound sutured with a regular non-coated suture
|
|
Eksperimentel: triclosan
Experimental group will receive abdominal wound closure with suture matherial that is coated with triclosan
|
The patients in the treated arm will have the abdominal wound sutured with triclosan-coated suture
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of surgical site infection
Tidsramme: 30 days
|
the incidence of superficial and deep wound infection in patients who underwent colorectal resection will be determined by a blind observer according to the Atlanta CDC definition. The unit of measure will be number of wound infection over the number of treated or control patients |
30 days
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
overall wound complications
Tidsramme: 30 days
|
30 days
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
længde af hospitalsophold
Tidsramme: 30 dage
|
30 dage
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Angelo Nespoli, MD, Milano-Bicocca University
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CR-SSI 09
- UNIMIB18 (Anden identifikator: Milano-Bicocca University)
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