A Study Comparing Skin Adhesive With Staple for Surgical Incision Closure After Laparoscopic / Robotic Bowel Resection

Study Overview
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Brief Summary
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INTRODUCTION Liquid skin adhesive (LSA) has benefits over other closure methods. Especially it is less invasive, quicker to apply, and better in cosmesis. Also LSA applied wounds need no post-care and its water-proof nature allows patients to take a shower immediate postoperative periods. While traditional sutures and skin staples are invasive and have infection chance requiring regular wound dressings, LSA is resistant against both water and microbial infection without need for postoperative dressings. Thus LSA-applied wounds need no professional care saving wound management cost. This study investigated not only the safety and efficacy of LSA, but also the cost-effectiveness in the context of total wound management resources including man-power, time, and cost. STUDY OBJECTIVE Primary end point of this study is time requiring to manage surgical wound calculated as man hour. Secondary end points are wound related complication and cost for management of surgical wound. STATISTICAL ANALYSIS The target number of the enrollment were calculated under the hypothesis that the wound management time for stapler group would be 1560 sec and that for LSA group be 264 sec with 10% drop-out rate. The sample number calculation formula of the t-test for independent 2 groups were used. For two-sided validation with the significance level of 0.05, and the power of 0.8, 29 patients for each group were estimated.

Detailed Description
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STUDY DESIGN Screening: replaced with preoperative examination chest X-ray, CBC, CEA, BUN/Cr, OT/PT, glucose, EKG, abdominopelvic CT (optional), chest CT (optional), PET-CT(optional), MRI(optional) Subject Experimental group: surgical wound closure with liquid skin adhesive Control group: surgical wound closure with stapler Randomization The patients were randomized just before surgery after anesthesia and were randomly assigned to either experimental or control group as to computer-generated random number in 1:1 manner. Study schedule The enrolled patients received an elective surgery within 30 days after screening. Surgical wound managers checked every enrolled patient from immediate postoperative period until discharge at least 1 time per day. Surgical wound managers were either surgical hospitalists (general surgery boards), surgical residents, or wound care specialist nurses. Incompletely healed wounds until discharge were managed regularly in out-patient clinics additionally. If wound complications were noted at any time point, standard treatment was given according to the patient's status regardless of assigned groups Wound management Wound healing time was defined as the time period from the moment of skin closure to the point when a surgical wound manager declared that the wound was healed either during admission or in out-patient clinic. For LSA group, wound closure time was measured in second starting from when LiquiBand® was applied to the first skin incision to when LiquiBand® was completely dried up in all skin incisions. For stapler group, it was measured as the whole time in second spent to apply skin staplers to all skin incisions in about 1cm interval without any dehiscence. Surgical wound management was performed at least once a day in all patients. Wound management time was measured when surgical wound manager inspected and performed wound dressing as required. It was defined as time in second starting from the moment a patient completely took off tops to the moment a surgical wound manager took off gloves on the completion of dressing. The complete wound healing was declared by surgical wound managers for wounds that have injections less than 2mm, no skin color change on the edges, no dehiscence on the inspection under white light. Wound management time and cost were analyzed separately for event places (during admission - and out-patient clinic). Wound management time was compensated as to surgical wound managers and converted in to man-hour. The compensation constant was defined to reduce bias by performer assuming the skill level of wound management was different among surgical wound managers. The surgical hospitalists who were general surgery boards were found to be the most skillful, therefore the constant for them was defined as 1. The constants for surgical residents and wound care specialist nurses were defined as 0.6 and 0.8 respectively. The total wound management cost included dressing fee and material cost. Generally, for normal wounds, adhesive foam dressings were used and for complicated wounds, gauzes and vicryl sutures were used as necessary. In Korean National Insurance System, dressing material costs were classified as the benefit service charge which was reimbursed by National Health Insurance Cooperation (NHIC) and the non-benefit service charge which a patient should pay all. Every dressing material was check whether the benefit service or the non-benefit service and the cost was recorded accordingly.

Official Title
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A Prospective Randomized Controlled Trial Comparing Cyanoacrylate Skin Adhesive With Staple for Surgical Incision Closure After Laparoscopic / Robotic Bowel Resection

Conditions
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Benign or Malignant Diseases With Indication for Laparoscopic or Robotic Colorectal Resection

Intervention / Treatment
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* Procedure: LSA (liquid skin adhesive)
* Procedure: stapler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A. 19-year-old or older adults B. elective laparoscopic or robotic colorectal resection C. clean-contaminated surgery without any intraoperative contamination D. The longest incision should be 15cm or shorter E. participant should voluntarily sign inform consent form Exclusion Criteria: A. emergency surgery or conversion-to-open surgery B. the longest skin incision longer than 15cm C. intraoperative contamination due to intestinal perforation or any other reason D. ECOG grade 3 or higher E. patients who are not be able to receive surgery within 30 days after screening F. patients who are refused to sign the informed consent form voluntarily

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized controlled, open-label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LSA (liquid skin adhesive)<br>surgical wound closure with liquid skin adhesive (LiquiBand®) | Procedure: LSA (liquid skin adhesive)<br>* surgical wound closure with liquid skin adhesive (LiquiBand®)<br>|
| Active Comparator: Stapler<br>surgical wound closure with stapler | Procedure: stapler<br>* surgical wound closure with stapler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total management time of surgical wound | Wound management time was defined as the time period from the moment of skin closure to the point when the wound was healed either during admission or in out-patient clinic. For LSA group, skin closure time was measured in second starting from when LiquiBand® was applied to the first skin incision to when LiquiBand® was completely dried up in all skin incisions. For stapler group, it was measured as the whole time in second spent to apply skin staplers to all skin incisions in about 1cm interval. Wound management was performed at least once a day in all patients. Time was measured when surgical wound manager inspected and performed wound dressing as required. It was defined as time in second starting from the moment a patient completely took off tops to the moment a surgical wound manager took off gloves on the completion of dressing. | postoperative day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical wound related complication | Surgical wound related complication is classified as erythema, edema, tenderness, inflammation, discharge, surgical site infection and dehiscence. | postoperative day 60 | 
| Total management costs of surgical wound | The total wound management cost included dressing fee and material cost. Generally, for normal wounds, adhesive foam dressings were used and for complicated wounds, gauzes and vicryl sutures were used as necessary. In Korean National Insurance System, dressing material costs were classified as the benefit service charge which was reimbursed by National Health Insurance Cooperation (NHIC) and the non-benefit service charge which a patient should pay all. Every dressing material was check whether the benefit service or the non-benefit service and the cost was recorded accordingly. | postoperative day 60 |