Pilotstudie om effektiviteten och säkerheten hos OPTILENE® SILVER MESH ELASTIC för att förebygga infektioner på operationsställen (SSI) och incisionsbråck (IH) (SSIHLVER)
Prospektiv beskrivande multicenterpilotstudie om effektiviteten och säkerheten hos Optilene® Silver Mesh Elastic för att förebygga kirurgiska infektioner (SSI) och incisionsbråck (IH)
The aim of the study is to describe the effectiveness of Optilene® Silver Mesh Elastic on prevention of surgical site infection (SSI) at 6 months follow-up in patients undergoing urgent laparotomy by collecting clinical data on the SSI rates, IH rates and overall clinical performance of Optilene® Silver Mesh Elastic used for the prevention of incisional hernia as prophylactic mesh in patients that require urgent median laparotomy in clinical routine.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Irene Fita Esteban
- Telefonnummer: +34609054401
- E-post: info@bbraun.com
Studera Kontakt Backup
- Namn: José Manuel Molina Villar
- Telefonnummer: +34697502623
- E-post: info@bbraun.com
Studieorter
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-
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Badalona, Spanien, 08916
- Hospital Universitari Germans Tries i Pujol
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Kontakt:
- Joan Francesc Julián, Dr.
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Huvudutredare:
- Joan Francesc Julián, Dr.
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Badalona, Spanien
- Hospital Municipal Badalona
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Kontakt:
- Jorge Marroquin, Dr.
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Huvudutredare:
- Jorge Marroquin, Dr.
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Calella, Spanien, 08370
- Hospital Comarcal Sant Jaume de Calella
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Kontakt:
- Paqui Vasco, Dr.
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Huvudutredare:
- Paqui Vasco, Dr.
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Mataró, Spanien, 08304
- Hospital de Mataró
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Kontakt:
- Berhanu Chimdi, Dr.
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Huvudutredare:
- Berhanu Chimdi, Dr.
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Santa Coloma de Gramenet, Spanien, 08923
- Hospital Fundació Esperit Sant
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Kontakt:
- Daniel Troyano Escribano, Dr.
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Huvudutredare:
- Daniel Troyano Escribano, Dr.
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
High-risk patients according to the professional criteria (such as but not limited to: age, nutrition, body mass index, comorbidities, etc.) who are undergoing prophylactic mesh implantation to avoid surgical site infection after an emergency or urgent intra-abdominal laparotomy.
Beskrivning
Inclusion Criteria:
- Adult patients (18 years or older)
- Surgical procedure requiring urgent, primary median laparotomy, which are classified as "Class III/Contaminated" or "Class IV/Dirty-Infected" regarding the CDC classification.
These include but are not limited to:
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Vascular surgery
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Colon and rectum
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Hepatobiliary
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Gastrointestinal
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Gynecology
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Urology
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Abdominal Aortic Aneurysm (AAA) repair
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Right hemicolectomy
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Left hemicolectomy
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Sigmoidectomy
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Anterior resection
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Abdominoperineal amputation
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Exploratory laparotomy
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Cholecystectomy
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Cholecystectomy and choledocotomy
- Written informed consent
Exclusion Criteria:
- Pregnancy
- Breast feeding
- Patients < 18 years old or patients who are still in the growth phase
- Contaminated and infected areas
- Hypersensitivity to silver
- Direct contact with the viscera
- Previous allergic reactions to components of the device
- Patient with previous laparotomy
- Transverse laparotomy
- Patients with previous hernia repair
- Simultaneous participation in another investigational clinical trial (drug or medical studies)
- Patients with active oncologic treatment (chemo and radiotherapy)
- Underlying autoimmune disease
- Recent cardiovascular complication
- Gynecology surgery
- Urology surgery
- Vascular surgery
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Optilene® Silver Mesh Elastic
Prophylactic mesh in high-risk patients |
Prevention of incisional hernia after a prophylactic mesh in high-risk patients |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Surgical Site Infection (SSI) A2/A3 rate
Tidsram: at 6 months follow-up
|
SSIs remain a significant clinical problem as they are associated with substantial mortality and morbidity and impose severe demands on healthcare resources. Centers for Disease Control and Prevention Surgical Site Infection (SSI) Classification System differentiates Superficial SSI (A1), Deep Incisional SSI (A2) and Infection with involvement of organs/body cavities (A3). Only cases of A2 and A3 are considered for the Primary Outcome and are compared to rates from reference literature |
at 6 months follow-up
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cumulative rate of of postoperative complications during the study period
Tidsram: at discharge (up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up
|
Numbers of all postoperative complications such as mortality, burst abdomen, bowel obstruction, bulging, necrosis, fistula, wound dehiscence, hematoma, seroma, peritonitis are added to the overall complication rate that is observed over the postoperative course |
at discharge (up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up
|
|
Cumulative Surgical Site Infection (SSI) A2/A3 rate during the study period
Tidsram: at 1 month, 1 year and 2 year follow-up.
|
Number of the Surgical Site Infection (SSI) (only A2 and A3) rate at every follow-up |
at 1 month, 1 year and 2 year follow-up.
|
|
Incisional hernia (IH) rate during the study period
Tidsram: repeatedly at 6 months, 1 year and 2 year follow-up.
|
Incisional hernia (IH) is a protrusion of tissue that forms at the site of a healing surgical scar. Incisional hernia refers to abdominal wall hernia at the site of a previous surgical incision. |
repeatedly at 6 months, 1 year and 2 year follow-up.
|
|
Length of hospital stay
Tidsram: at discharge (approximately up to 10 days after surgery)
|
Number of days the patient has to stay in hospital after the surgery |
at discharge (approximately up to 10 days after surgery)
|
|
Development of Pain: Visual Analogue Scale (VAS)
Tidsram: at discharge (approximately up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up, using the VAS score
|
This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain". |
at discharge (approximately up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up, using the VAS score
|
|
Time to return to work
Tidsram: at all postoperative examinations with a single value for each individual patient
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The number of days needed to return to work after the surgery of the individual patient is documented |
at all postoperative examinations with a single value for each individual patient
|
|
Handling of the Optilene® Silver Mesh Elastic
Tidsram: intraoperatively
|
The handling will be evaluated using a questionnaire (Likert-type scale) with the dimensions Tensile Strength, Absence of memory effect, Elasticity, Stiffness, Surface weight, Thickness, Ease of being fixed with suture, Ease of package extraction as well as an overall opinion in five evaluation levels (excellent=1, very good=2, good=3, satisfied=4, poor=5) |
intraoperatively
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Daniel Troyano Escribano, Dr., Fundació Hospital de l'Esperit Sant
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AAG-G-H-2126
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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