Clinical trial NCT06549803: Comparison of Method for Skin Closure in Colorectal Cancer.
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Surgical Site Infection
Colorectal Cancer
Keywords: colorectal cancer
skin adhesive bond
skin stapling
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Dalim BioTech Co., Ltd.
First posted: 2024-08-12
Enrollment: 304
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* underwent elective colorectal surgery
* aged 19 to 80 years
* ASA (American Society of Anesthesiologists) score: 1, 2
* surgical approach such as laparoscopic or Robotic Xi platform

Exclusion Criteria:

* ASA score above 3
* Aged over 80 years
* underwent combined surgery for other organ resection
* uncontrolled DM

Primary outcomes:
measure: incidence of surgical site infection within 30 days after surgery
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Postoperative pain score
timeFrame: through study completion, an average of 1 year
measure: Postoperative wound dressing cost
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's hospital, the Catholic university of Korea
state: Seocho
Study officials:
affiliation: Department of Surgery, Seoul St.Mary's hospital
name: Yoon Suk Lee, M.D.,Ph.D
role: STUDY_CHAIR
References:
citation: Yahara S, Kishimoto Y. Characterization of alkylgalactolipids from calf brain by high performance liquid chromatography. J Neurochem. 1981 Jan;36(1):190-4. doi: 10.1111/j.1471-4159.1981.tb02394.x.