Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection

Surgical Site Infection Clinical Trial

Official title:

Intraoperative Irrigation of the Surgical Incision With Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06302335
• Other study ID #: 2022-0442
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Daniel C Damin, PhD
• Phone: +5551996020442
• Email: damin[@]terra.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Considering the relatively high incidence of surgical site infection (SSI) in colorectal surgery, this trial will compare rates of SSI in patients undergoing colorectal resections followed by surgical wound irrigation with povidone-iodine versus the group of patients undergoing surgical wound irrigation with saline solution. The trial will be conducted in a large university hospital in Southern Brazil.

Description:

Patients will be randomized to one of the following intervention groups: Group 1: intraoperative irrigation/washing of the surgical incision with povidone-iodine (PVP-I); Detail: after aponeurotic synthesis and immediately before cutaneous synthesis, the skin and subcutaneous tissue of the surgical incision will be irrigated and washed abundantly with approximately 500ml (depending on the size of the incision) of povidone-iodine solution (PVP-I). The exact volume to be used will be the minimum volume necessary for abundant and efficient washing of the incision tissues. " Group 2: intraoperative irrigation/washing of the surgical incision with saline solution (NaCl 0.9%); Detail: after aponeurotic synthesis and immediately before cutaneous synthesis, the skin and subcutaneous tissue of the surgical incision will be irrigated and washed abundantly with approximately 500ml (depending on the size of the incision) of saline solution (NaCl 0.9%). The exact volume to be used will be the minimum volume necessary for abundant and efficient washing of the incision tissues. NOTE: other care routines for participating patients will not be changed by this study. Patients will receive mechanical colon preparation and antibiotic prophylaxis according to routines already in place by the assistant team. Randomization: the block randomization method will be used (blocks of 4 patients each). Groups 1 and 2 will be compared with each other regarding the outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients older than 18 years of age diagnosed with benign or malignant colorectal diseases undergoing elective open or video-assisted colectomy or proctectomy (resection) at the Hospital de Clinicas de Porto Alegre - Division of Coloproctology.

Exclusion Criteria:

• age under 18;
• surgery classified as dirty;
• urgent/emergency surgery;
• patients undergoing multi-visceral resections (pelvic exenteration or partial resection of any adjacent organ);
• known allergy to iodine.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Povidone-iodine
Application of Povidone-iodine to the surgical wound of patients submitted to colorectal resections.
• Saline solution
Application of saline solution to the surgical wound of patients submitted to colorectal resections.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection	Surgical site infection within 30 days from the surgical procedure	30 days
Secondary	Intracavitary surgical infection	Infections within the abdominal cavity	30 days