Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90.035-903, Brazil
Location status: Recruiting
NCT Number: NCT06302335
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Porto Alegre, Rio Grande do Sul, 90.035-903, Brazil
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Application of Povidone-iodine to the surgical wound of patients submitted to colorectal resections.
Application of saline solution to the surgical wound of patients submitted to colorectal resections.
Time frame: 30 days
Surgical site infection within 30 days from the surgical procedure
Time frame: 30 days
Infections within the abdominal cavity
Contact information is provided by the study sponsor or research team.
Hospital de Clinicas de Porto Alegre
Other
Intraoperative Irrigation of the Surgical Incision With Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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