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

Phase 4

Not yet recruiting

• Conditions: Surgical Site Infection; Surgical Procedures, Operative
• Interventions: Combination Product: Standard bundle; Combination Product: Polihexanide-based bundle

• Registration Number: NCT06338163
• Lead Sponsor: Marco Catarci

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-03-23
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-03-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-04
• Study Start: 2024-07-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Standard bundle	Once a day starting 5 days before the operation: Total body washing with usual soap/shampoo. No oral and nasal MDRO-decolonization will be performed. After the closure of fascia, 10 minutes subcutaneous irrigation with 50 to 250 mL (according to incision length) NS will be performed. After the end of the application time, a subcutaneous swab for culture will be taken. Finally, standard wound(s) dressing(s) (according to local center clinical practice) will be applied.
Treatment	Polihexanide-based bundle	Once a day starting 5 days before the operation: Total body washing with usual soap/shampoo and single-use washcloths impregnated with a mix of Polihexanide, surfactants, and excipients. Nasal cleaning 3 times a day with a Polihexanide Nasal Gel Oral gargles 3 times a day using 10 mL of a Polihexanide oral solution. After the closure of fascia, 10 minutes subcutaneous irrigation with 50 to 250 mL (according to incision length) of antiseptic solution will be performed using a 0.04% sterile Polihexanide solution. After the end of the application time, a subcutaneous swab for culture will be taken. Before standard (according to local center clinical practice) wound(s) dressing(s), a 3 mm-thick antiseptic gel (a combination comprised of 0.1 % Polihexanide and 0.1 % propyl betaine (surfactant) that is used for cleansing, moistening and decontamination of post-operative wounds) will be applied on any wound(s).

Primary Outcome Measures

Name	Time	Method
Infectious morbidity rates	60 days after surgery	SSI + urinary tract infection + pulmonary infection
Surgical Site Infections rate	60 days after surgery	CDC definition
Incisional (superficial and deep) Surgical Site Infections rate	60 days after surgery	CDC definition

Secondary Outcome Measures

Name	Time	Method
Anastomotic leakage rates	60 days after surgery	According to international consensus
Overall morbidity rates	60 days after surgery	Any adverse event
Major morbidity rates	60 days after surgery	Any adverse event grade \> II according to Clavien-Dindo
Comprehensive complication index	60 days after surgery	According to Slankamenac et al 2013
Overall length of postoperative hospital stay	60 days after surgery	inclusive of any unplanned readmission
Readmission rates	60 days after surgery	any unplanned readmission after primary discharge

Trial Locations

Locations (3)

OSpedale Santa Maria Annunziata; 🇮🇹 Firenze, FI, Italy

Ospedale Civile di Macerata; 🇮🇹 Macerata, MC, Italy

Ospedale Sandro Pertini; 🇮🇹 Roma, RM, Italy