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

NCT04969016 · Yonsei University · Updated 20 July 2021

What is being tested
LSA (liquid skin adhesive); stapler
For
Benign or Malignant Diseases With Indication for Laparoscopic or Robotic Colorectal Resection
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 19 years and older. About 58 people. The full rules are on the registry page.
Where
South Korea
When
Starts or started 18 Nov 2020, ends 22 Oct 2021. Registered 20 July 2021.
Results
None posted yet.

In the researchers' words

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…
ClinicalTrials.gov, NCT04969016

Sites

  • Severance Hospital, Yonsei University Health SystemSeoul, South Korea