Surgical Site Infection Clinical Trial
— POSSIBLEOfficial title:
Polihexanide SSIs Measures Bundle (PSMB) During Enhanced Recovery After Major Digestive Surgery
This is a randomized controlled, prospective, multicenter superiority trial with two parallel treatment groups and single blinding (local investigators performing postoperative follow up will be blinded for group allocation), with prospective enrollment planned from July 2024 to June 2025 in 20 Italian surgical centers. All patients undergoing elective major gastro-intestinal (GI) tract surgery (upper GI, HPB, & lower GI) will be included in a prospective database after written informed consent. A total of 2,000 patients is expected based on a mean of 100 cases per center.
Status | Not yet recruiting |
Enrollment | 2000 |
Est. completion date | September 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients submitted to laparoscopic/robotic/open/converted major digestive surgery (upper and lower gastrointestinal resections). - American Society of Anesthesiologists' (ASA) class I, II, III or IV - Elective surgery - Patients' written acceptance to be included in the study. Exclusion Criteria: - American Society of Anesthesiologists' (ASA) class V - Urgent surgery - Pregnancy - Hyperthermic intraperitoneal chemotherapy for carcinomatosis. |
Country | Name | City | State |
---|---|---|---|
Italy | OSpedale Santa Maria Annunziata | Firenze | FI |
Italy | Ospedale Civile di Macerata | Macerata | MC |
Italy | Ospedale Sandro Pertini | Roma | RM |
Lead Sponsor | Collaborator |
---|---|
Marco Catarci | Associazione Chirurghi Ospedalieri Italiani |
Italy,
Allegranzi B, Bischoff P, de Jonge S, Kubilay NZ, Zayed B, Gomes SM, Abbas M, Atema JJ, Gans S, van Rijen M, Boermeester MA, Egger M, Kluytmans J, Pittet D, Solomkin JS; WHO Guidelines Development Group. New WHO recommendations on preoperative measures for surgical site infection prevention: an evidence-based global perspective. Lancet Infect Dis. 2016 Dec;16(12):e276-e287. doi: 10.1016/S1473-3099(16)30398-X. Epub 2016 Nov 2. — View Citation
Berrios-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP; Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017 Aug 1;152(8):784-791. doi: 10.1001/jamasurg.2017.0904. Erratum In: JAMA Surg. 2017 Aug 1;152(8):803. — View Citation
Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2. — View Citation
Katayama H, Kurokawa Y, Nakamura K, Ito H, Kanemitsu Y, Masuda N, Tsubosa Y, Satoh T, Yokomizo A, Fukuda H, Sasako M. Extended Clavien-Dindo classification of surgical complications: Japan Clinical Oncology Group postoperative complications criteria. Surg Today. 2016 Jun;46(6):668-85. doi: 10.1007/s00595-015-1236-x. Epub 2015 Aug 20. — View Citation
Mueller TC, Loos M, Haller B, Mihaljevic AL, Nitsche U, Wilhelm D, Friess H, Kleeff J, Bader FG. Intra-operative wound irrigation to reduce surgical site infections after abdominal surgery: a systematic review and meta-analysis. Langenbecks Arch Surg. 2015 Feb;400(2):167-81. doi: 10.1007/s00423-015-1279-x. Epub 2015 Feb 14. — View Citation
Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11. — View Citation
Strobel RM, Leonhardt M, Krochmann A, Neumann K, Speichinger F, Hartmann L, Lee LD, Beyer K, Daum S, Kreis ME, Lauscher JC. Reduction of Postoperative Wound Infections by Antiseptica (RECIPE)?: A Randomized Controlled Trial. Ann Surg. 2020 Jul;272(1):55-64. doi: 10.1097/SLA.0000000000003645. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient-reported outcome measures | MD Anderson Symptom Inventory for Gastrointestinal Surgery | preoperative, at discharge, 60 days after surgery | |
Primary | Surgical Site Infections rate | CDC definition | 60 days after surgery | |
Primary | Incisional (superficial and deep) Surgical Site Infections rate | CDC definition | 60 days after surgery | |
Primary | Infectious morbidity rates | SSI + urinary tract infection + pulmonary infection | 60 days after surgery | |
Secondary | Anastomotic leakage rates | According to international consensus | 60 days after surgery | |
Secondary | Overall morbidity rates | Any adverse event | 60 days after surgery | |
Secondary | Major morbidity rates | Any adverse event grade > II according to Clavien-Dindo | 60 days after surgery | |
Secondary | Comprehensive complication index | According to Slankamenac et al 2013 | 60 days after surgery | |
Secondary | Overall length of postoperative hospital stay | inclusive of any unplanned readmission | 60 days after surgery | |
Secondary | Readmission rates | any unplanned readmission after primary discharge | 60 days after surgery |
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