Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:41 PM
Study NCT ID:
NCT06302335
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: