Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549803
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Comparison of Method for Skin Closure in Colorectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Study on Comparison of Postoperative Outcome Between Conventional Skin Stapling and Tissue Adhesive 2-octyl Cyanoacrylate for Skin Closure in Colorectal Cancer
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Compared to tissue adhesives and skin stapling devices tissue adhesives are reported to have advantages in terms of wound infection and cost competitiveness However there have been no prospective randomized studies focusing on wound infection rates and cost competitiveness between skin stapling devices and tissue adhesives in colorectal cancer surgery
In colon cancer surgery it is still unclear which skin suturing method has advantages such as lower postoperative wound infection rate and price competitiveness The purpose of this study is to compare clinical outcomes including wound infection rates and cost-effectiveness between two different wound closure methods for colorectal cancer
In colon cancer surgery it is still unclear which skin suturing method has advantages such as lower postoperative wound infection rate and price competitiveness The purpose of this study is to compare clinical outcomes including wound infection rates and cost-effectiveness between two different wound closure methods for colorectal cancer
Detailed Description:
The primary purpose of the study is to compare and analyze the incidence of surgical site infection within 30 days after surgery in each group when tissue adhesive was applied and when skin stapling device was applied
The purpose of the secondary study is to compare the clinical results after surgery by analyzing cost-effectiveness pain level and satisfaction after surgery between existing skin stapling and tissue adhesive for colon cancer patients
Post-operative wound infection rate cost material costs of staplers adhesives material costs and service fees for disinfecting wounds occurring in the week after surgery sex age BMI body mass index ASA Anesthesiologists category past history diabetes smoking history past abdominal surgery history cancer stage pre- and post-operative blood test results WBC CRP biopsy results cancer type surgery time pain on the 1st and 3rd days after surgery VAS length of stay postoperative complications compare the postoperative results of satisfaction
The purpose of the secondary study is to compare the clinical results after surgery by analyzing cost-effectiveness pain level and satisfaction after surgery between existing skin stapling and tissue adhesive for colon cancer patients
Post-operative wound infection rate cost material costs of staplers adhesives material costs and service fees for disinfecting wounds occurring in the week after surgery sex age BMI body mass index ASA Anesthesiologists category past history diabetes smoking history past abdominal surgery history cancer stage pre- and post-operative blood test results WBC CRP biopsy results cancer type surgery time pain on the 1st and 3rd days after surgery VAS length of stay postoperative complications compare the postoperative results of satisfaction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None