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

NCT04969016 | Unknown

• 1 other identifier: 4-2020-1023
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Surgical wound related complication

  postoperative day 60

• Total management costs of surgical wound

  postoperative day 60

Study Arms (2)

LSA (liquid skin adhesive)

EXPERIMENTAL

surgical wound closure with liquid skin adhesive (LiquiBand®)

Procedure: LSA (liquid skin adhesive)

Stapler

ACTIVE COMPARATOR

surgical wound closure with stapler

Procedure: stapler

Interventions

LSA (liquid skin adhesive) PROCEDURE

surgical wound closure with liquid skin adhesive (LiquiBand®)

LSA (liquid skin adhesive)

stapler PROCEDURE

surgical wound closure with stapler

Stapler

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

RECRUITING

Related Publications (15)

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MeSH Terms

Interventions

Surgical Staplers

Intervention Hierarchy (Ancestors)

Surgical Instruments; Surgical Equipment; Equipment and Supplies

Study Officials

• Byung Soh Min

  Severance Hospital, Yonsei University Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Byung Soh Min

CONTACT

82-10-7677-5679; BSMIN@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized controlled, open-label

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 20, 2021
• Study Start: November 18, 2020
• Primary Completion: October 22, 2021
• Study Completion: October 22, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)