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Trial Title:
Comparison of Method for Skin Closure in Colorectal Cancer.
NCT ID:
NCT06549803
Condition:
Surgical Site Infection
Colorectal Cancer
Conditions: Official terms:
Surgical Wound Infection
Colorectal Neoplasms
Conditions: Keywords:
colorectal cancer
skin adhesive bond
skin stapling
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
skin bond
Description:
In the skin bond group, fascia closure is performed for incision sites of 10 mm or more,
and skin bond is sufficiently applied after subcuticular suture.
For incision sites less than 10 mm, subcuticular closure is performed without closing the
fascia, and then skin bond is applied.
Arm group label:
Skin adhesive bond
Intervention type:
Device
Intervention name:
skin stapler
Description:
In the skin stapler group, fascia closure is performed on incision sites larger than 10
mm, and the skin is closed at 2-3 mm intervals using a stapler.
For incision sites less than 10 mm, skin closure is performed using a skin stapler
without closing the fascia.
Arm group label:
skin stapler
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.
Criteria for 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
Gender:
All
Minimum age:
19 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Seoul St.Mary's hospital, the Catholic university of Korea
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Start date:
March 1, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Yoon Suk Lee
Agency class:
Other
Collaborator:
Agency:
Dalim BioTech Co., Ltd.
Agency class:
Industry
Source:
Seoul St. Mary's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06549803
