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

NCT06338163 | Not Yet Recruiting Phase 4

• 1 other identifier: POSSIBLE 1.6
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Surgical Site Infection; Surgical Procedures, Operative

Keywords

surgical site infection; polihexanide; preoperative decontamination

Outcome Measures

Primary Outcomes (3)

• Surgical Site Infections rate

  CDC definition

  60 days after surgery

• Incisional (superficial and deep) Surgical Site Infections rate

  CDC definition

  60 days after surgery

• Infectious morbidity rates

  SSI + urinary tract infection + pulmonary infection

  60 days after surgery

Secondary Outcomes (6)

• Anastomotic leakage rates

  60 days after surgery

• Overall morbidity rates

  60 days after surgery

• Major morbidity rates

  60 days after surgery

• Comprehensive complication index

  60 days after surgery

• Overall length of postoperative hospital stay

  60 days after surgery

Other Outcomes (1)

• Patient-reported outcome measures

  preoperative, at discharge, 60 days after surgery

Study Arms (2)

Treatment

EXPERIMENTAL

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).

Combination Product: Polihexanide-based bundle

Control

ACTIVE COMPARATOR

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.

Combination Product: Standard bundle

Interventions

Polihexanide-based bundle COMBINATION_PRODUCT

Pre- and intra-operative decontamination will be accomplished in the treatment (experimental) arm with Polihexanide-based products

Also known as: Prontoderm® Wipes (B. Braun Medical AG, Sempach, Switzerland), Prontoderm® Nasal Gel (B. Braun Medical AG, Sempach, Switzerland), ProntOral® (B. Braun Medical AG, Sempach, Switzerland), LavaSurge® (B. Braun Medical AG, Sempach, Switzerland)

Treatment

Standard bundle COMBINATION_PRODUCT

Pre- and intra-operative decontamination will be accomplished in the control arm with normal soap/shampoo and saline solution

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• American Society of Anesthesiologists' (ASA) class V
• Urgent surgery
• Pregnancy
• Hyperthermic intraperitoneal chemotherapy for carcinomatosis.

Sponsors & Collaborators

• Marco Catarci: lead
• Associazione Chirurghi Ospedalieri Italiani: collaborator

Study Sites (3)

OSpedale Santa Maria Annunziata

Florence, FI, 50012, Italy

Location

Ospedale Civile di Macerata

Macerata, MC, 62100, Italy

Location

Ospedale Sandro Pertini

Roma, RM, 00157, Italy

Location

Related Publications (7)

• 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.

  PMID: 19638912 BACKGROUND

• 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.

  PMID: 26289837 BACKGROUND

• 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.

  PMID: 31599810 BACKGROUND

• 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.

  PMID: 20004450 BACKGROUND

• 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.

  PMID: 27816413 BACKGROUND

• 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.

  PMID: 28467526 BACKGROUND

• 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.

  PMID: 25681239 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Catarci, MD, FACS

  Associazione Chirurghi Ospedalieri Italiani

  STUDY CHAIR

• Massimo Sartelli, MD

  Ospedale di Macerata

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Scatizzi, MD

CONTACT

+393492197687; marcoscatizzi60@gmail.com

Mario Campli, MD

CONTACT

+393939038353; segreteria@acoi.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor of the primary outcome will be masked concerning arm allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Chair

Model Details: Randomized controlled prospective multicenter

Study Record Dates

• First Submitted: March 23, 2024
• First Posted: March 29, 2024
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

IT (3)