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| Name | Class |
|---|---|
| Dalim BioTech Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skin adhesive bond | Experimental | a group which skin closure was performed using Leukosan Adhesive skin bond |
|
| skin stapler | Active Comparator | a group which skin closure was performed using skin stapler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| skin bond | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoon Suk Lee, M.D.,Ph.D | Department of Surgery, Seoul St.Mary's hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St.Mary's hospital, the Catholic university of Korea | Seoul | Seocho | 06591 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32908846 | Result | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2022 | Apr 5, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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|
| skin stapler | Device | 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. |
|
| Postoperative wound dressing cost | Postoperative wound dressing cost between existing skin stapling and tissue adhesive for colon cancer patients. | through study completion, an average of 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |