Polihexanide SSIs Measures Bundle (PSMB) During Enhanced Recovery After Major Digestive Surgery

Surgical Site Infection Clinical Trial

— POSSIBLE  

Official title:

Polihexanide SSIs Measures Bundle (PSMB) During Enhanced Recovery After Major Digestive Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06338163
• Other study ID #: POSSIBLE 1.6
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 1, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2024
• Source: Ospedale Sandro Pertini, Roma
• Contact: Marco Scatizzi, MD
• Phone: +393492197687
• Email: marcoscatizzi60[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Just after signing a written informed consent to participate, patients will randomly be assigned either to the experimental group (Polihexanide bundle) or to the control group. Block randomization (blocks of 10 patients per single participating center) will be performed using an unstratified computer generated randomization list. All operations will be performed according to local criteria of the participating center. Hair removal will be accomplished on the day of surgery with electronic clippers. Alcohol-based solutions of chlorhexidine for surgical site skin preparation will be used. A first dose of perioperative i.v. antibiotics will be administered 30 minutes before skin incision (choice of the antibiotic according to local criteria) in all patients. Additional intraoperative doses will be administered for procedures exceeding two half-lives of the antibiotic. At the end of the operation, the peritoneal cavity will be rinsed routinely with 0.9% sodium chloride solution (normal saline, NS) at body temperature. Before closure of fascia, instruments and gloves will be changed. The eventual placement of drain(s) in the peritoneal cavity and/or creation of an intestinal stoma will be recorded. No subcutaneous suture or drainage will be done. Skin will be closed with either staples, intracutaneous running suture or interrupted sutures.

Potential patient-specific and intraoperative risk factors will be recorded: sex, age, body mass index, nutritional status, frailty, indication to surgery (benign vs. malignant disease), perioperative administration of steroids, renal failure and dialysis, cardiovascular or respiratory disease, American Society of Anesthesiologist class, bowel preparation, type of approach, operative time, presence of peritoneal cavity drainage. During the postoperative period, patients will be examined by the attending surgeon daily. Fever (central temperature > 38 °C), pulse, abdominal signs, bowel movements, volume and aspect of drainage (if present) will be recorded daily. The local attending surgeon will make any decision for complementary exams and imaging according to his own criteria. The rate of any adverse event will be calculated and graded according to the Clavien-Dindo criteria [19] and to Japan Clinical Oncology Group Postoperative Complications (JCOG-PC) extended criteria [20], including all anastomotic leaks, wound infection (according to the definitions of the Centers for Disease Control and Prevention and wound culture), pneumonia (clinical symptoms, and physical and radiological examinations), central venous line infection (positive blood culture), urinary tract infection (positive urine culture with bacterial count). ERAS pathway items will be defined according to national [27] guidelines, measuring adherence upon explicit criteria. All data will be recorded for a minimum of 8 weeks (60 days) after surgery. PROM questionnaires will be administered to all enrolled patients four to one week before the planned operation, at discharge, and 6 to 8 weeks after the operation.

After anonymization, all data of each single case will be prospectively uploaded by local investigator(s) on a web-based database, protected by individual access credentials, and incorporated into a spreadsheet for data analysis. Any eventual discrepancy and/or mismatch will be checked, addressed and solved through strict cooperation between coordinating and local investigators.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Surgical Procedures, Operative
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Combination Product:
• Polihexanide-based bundle
Pre- and intra-operative decontamination will be accomplished in the treatment (experimental) arm with Polihexanide-based products
• Standard bundle
Pre- and intra-operative decontamination will be accomplished in the control arm with normal soap/shampoo and saline solution

Locations

Country	Name	City	State
Italy	OSpedale Santa Maria Annunziata	Firenze	FI
Italy	Ospedale Civile di Macerata	Macerata	MC
Italy	Ospedale Sandro Pertini	Roma	RM

Sponsors (2)

Lead Sponsor	Collaborator
Marco Catarci	Associazione Chirurghi Ospedalieri Italiani

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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

Outcome

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