Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06302335
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-03-04
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:
Hospital de Clinicas de Porto Alegre
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 irrigationwashing 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 irrigationwashing of the surgical incision with saline solution NaCl 09 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 09 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 irrigationwashing 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 irrigationwashing of the surgical incision with saline solution NaCl 09 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 09 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:
None
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?:
None