Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309368
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-02-22
Brief Title:
Ostomy Primary Closure With 01 Betaine01 Polyhexanide Wound Irrigation Compared to Pursestring Closure
Sponsor:
University of Nevada Las Vegas
Organization:
University of Nevada Las Vegas
Study Overview
Official Title:
To Close or Not to Close Surgical Site Infection Rates in Ostomy Primary Closure With 01 Betaine01 Polyhexanide Wound Irrigation Compared to Conventional Ostomy Closure by Secondary Intention
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:
The goal of this clinical trial is to compare two types of closure in patients with ostomies that are ready for closure The main questions it aims to answer are
1 Surgical site infection rates
2 Patient quality of life
3 Time to wound healing
Participants will undergo either complete ostomy wound closure after washing out the wound with Prontosan or their ostomy wound will be closed using the Pursestring method where the wound will be left partially open and allowed to heal from the inside out Researchers will compare these two groups outcomes questions to be answered as listed above
1 Surgical site infection rates
2 Patient quality of life
3 Time to wound healing
Participants will undergo either complete ostomy wound closure after washing out the wound with Prontosan or their ostomy wound will be closed using the Pursestring method where the wound will be left partially open and allowed to heal from the inside out Researchers will compare these two groups outcomes questions to be answered as listed above
Detailed Description:
Surgical site infection SSI is a common yet potentially serious and devastating complication in colorectal surgery with rates of up to 25 many of which are preventable In stoma closure SSI rates have been reported as up to 40 with conventional closure techniques SSI adds more burden to the patient requiring additional therapy such as antibiotics wound drainage and even wound debridement This results in longer hospital length of stay and can ultimately negatively impact a patients quality of life Additionally allowing a wound to heal by secondary intention has been demonstrated to have worse cosmetic outcomes compared to primary closure which may also impact quality of life QoL for patients The investigators aim to investigate the outcomes including SSI rates and QoL of patients who underwent two different standards of care in ostomy closure primary skin closure after usage of Prontosan a 01 betaine and 01 polyhexamethylene biguanide antimicrobial solution and secondary intention healing after Pursestring closure Comparing these two closure methods may yield further insight into better treatment options for wound closures in colorectal surgery patients
Patients will be recruited in the UNLV Colorectal Clinic at their appointments and surgeries will be done at University Medical Center Patient recruitment and informed consent will be performed by the co-investigators The sample size is calculated for a non-inferiority trial with a 25 level of significance 90 power of test and an expected SSI rate of 3 for the purse-string closure group and 259 for the primary wound closure without 01 betaine01 polyhexanide The sample size needed is 42 patients in each study arm with an assumed 20 attrition rate Data will be analyzed by the statistician
Patients will be recruited in the UNLV Colorectal Clinic at their appointments and surgeries will be done at University Medical Center Patient recruitment and informed consent will be performed by the co-investigators The sample size is calculated for a non-inferiority trial with a 25 level of significance 90 power of test and an expected SSI rate of 3 for the purse-string closure group and 259 for the primary wound closure without 01 betaine01 polyhexanide The sample size needed is 42 patients in each study arm with an assumed 20 attrition rate Data will be analyzed by the statistician
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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