Surgical Site InfectionNCT06549803
Comparison of Method for Skin Closure in Colorectal Cancer.
A study testing skin bond and skin stapler in people with Surgical Site Infection and Colorectal Cancer, run by Yoon Suk Lee at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Surgical Site Infection, Colorectal Cancer
- What is being tested?
- skin bond and skin stapler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- ASA score above 3
- Aged over 80 years
- underwent combined surgery for other organ resection
- uncontrolled DM
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul St.Mary's hospital, the Catholic university of Korea
Seoul, Seocho, 06591
About this study
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
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.
Read the 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.
- Conditions
- Surgical Site Infection, Colorectal Cancer
- Being tested
- skin bond, skin stapler
- Keywords
- colorectal cancer, skin adhesive bond, skin stapling
- Medical subject headings
- Surgical Wound Infection, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin bondDevice
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.
skin staplerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Skin adhesive bond | Experimental | a group which skin closure was performed using Leukosan Adhesive skin bond Receives: Device: skin bond |
| skin stapler | Active comparator | a group which skin closure was performed using skin stapler Receives: Device: skin stapler |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of surgical site infection within 30 days after surgery
Comparative analysis of the frequency of surgical site infection up to 1 month after surgery in each group when tissue adhesive was applied and when skin stapling device was applied.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Postoperative pain score
Post-operative pain score by VAS score were measured and compared with each other by understanding various factors through cost-effectiveness analysis, pain level, satisfaction, etc. after surgery between existing skin stapling and tissue adhesive for colon cancer patients.
Measured: through study completion, an average of 1 year
Postoperative wound dressing cost
Postoperative wound dressing cost between existing skin stapling and tissue adhesive for colon cancer patients.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Mar 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yoon Suk Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Dalim BioTech Co., Ltd.
- Responsible party
- Sponsor-investigator, Yoon Suk Lee, Seoul St. Mary's Hospital
- Investigators
- Yoon Suk Lee, M.D.,Ph.D, Study chair, Department of Surgery, Seoul St.Mary's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549803
- Sponsor's protocol ID
- KC21EISI0608
- Status last verified
- Dec 2025
- First submitted
- 3 Jul 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee CS, Han SR, Kye BH, Bae JH, Koh W, Lee IK, Lee DS, Lee YS. Surgical skin adhesive bond is safe and feasible wound closure method to reduce surgical site infection following minimally invasive colorectal cancer surgery. Ann Surg Treat Res. 2020 Sep;99(3):146-152. doi: 10.4174/astr.2020.99.3.146. Epub 2020 Aug 27.
PubMed 32908846
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06549803
- Acronym / sponsor ID
- KC21EISI0608
- Conditions
- Surgical Site Infection, Colorectal Cancer
- Keywords
- colorectal cancer, skin adhesive bond, skin stapling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Yoon Suk LeeUniversity, hospital or other
- Collaborators
- Dalim BioTech Co., Ltd.
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin adhesive bond | Experimental | Device: skin bonda group which skin closure was performed using Leukosan Adhesive skin bond |
| skin stapler | Active comparator | Device: skin staplera group which skin closure was performed using skin stapler |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- ASA score above 3
- Aged over 80 years
- underwent combined surgery for other organ resection
- uncontrolled DM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin bondIn 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. | Device | Skin adhesive bond |
| skin staplerIn 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. | Device | skin stapler |
Primary outcome
incidence of surgical site infection within 30 days after surgery
Time frame: through study completion, an average of 1 year
Comparative analysis of the frequency of surgical site infection up to 1 month after surgery in each group when tissue adhesive was applied and when skin stapling device was applied.
2 secondary outcomes
Postoperative pain score
Time frame: through study completion, an average of 1 year
Postoperative wound dressing cost
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Results publication: PubMed 32908846Lee CS, Han SR, Kye BH, Bae JH, Koh W, Lee IK, Lee DS, Lee YS. Surgical skin adhesive bond is safe and feasible wound closure method to reduce surgical site infection following minimally invasive colorectal cancer surgery. Ann Surg Treat Res. 2020 Sep;99(3):146-152. doi: 10.4174/astr.2020.99.3.146. Epub 2020 Aug 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoon Suk Lee, M.D.,Ph.D study chair
Department of Surgery, Seoul St.Mary's hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin bond and skin stapler in people with Surgical Site Infection and Colorectal Cancer, run by Yoon Suk Lee at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of surgical site infection within 30 days after surgery (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06549803, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.