Surgical Site Infection
Conditions
Keywords
surgical site infection, colorectal surgey
Brief 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.
Detailed 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.
Interventions
DRUGPovidone-iodine
Application of Povidone-iodine to the surgical wound of patients submitted to colorectal resections.
DRUGSaline solution
Application of saline solution to the surgical wound of patients submitted to colorectal resections.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants will not know what kind of substance will be used during the surgery.
Intervention model description
This a randomized clinical trial involving patients undergoing colorectal surgeries who will submitted to the application of povidone-iodine versus saline solution in their surgical sites.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infection | 30 days | Surgical site infection within 30 days from the surgical procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intracavitary surgical infection | 30 days | Infections within the abdominal cavity |
Countries
Brazil
Contacts
Primary ContactDaniel C Damin, PhD
Outcome results
None listed