Benign or Malignant Diseases With Indication for Laparoscopic or Robotic Colorectal ResectionNCT04969016
A Study Comparing Skin Adhesive With Staple for Surgical Incision Closure After Laparoscopic / Robotic Bowel Resection
A study testing LSA (liquid skin adhesive) and stapler in people with Benign or Malignant Diseases With Indication for Laparoscopic or Robotic Colorectal Resection, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Benign or Malignant Diseases With Indication for Laparoscopic or Robotic Colorectal Resection
- What is being tested?
- LSA (liquid skin adhesive) and stapler
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Nov 2020to 22 Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul
Byung Soh Min, 82-10-7677-5679, BSMIN@yuhs.ac
About this study
Official title: A Prospective Randomized Controlled Trial Comparing Cyanoacrylate Skin Adhesive With Staple for Surgical Incision Closure After Laparoscopic / Robotic Bowel Resection
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Benign or Malignant Diseases With Indication for Laparoscopic or Robotic Colorectal Resection
- Being tested
- LSA (liquid skin adhesive), stapler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSA (liquid skin adhesive)Procedure or surgery
surgical wound closure with liquid skin adhesive (LiquiBand®)
staplerProcedure or surgery
surgical wound closure with stapler
| Study group | Role | What they receive |
|---|---|---|
| LSA (liquid skin adhesive) | Experimental | surgical wound closure with liquid skin adhesive (LiquiBand®) Receives: Procedure: LSA (liquid skin adhesive) |
| Stapler | Active comparator | surgical wound closure with stapler Receives: Procedure: stapler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postoperative day 60
Secondary outcomes (2)
Surgical wound related complication
Surgical wound related complication is classified as erythema, edema, tenderness, inflammation, discharge, surgical site infection and dehiscence.
Measured: 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.
Measured: postoperative day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start18 Nov 2020
- Primary completion22 Oct 2021 (estimated)
- Study completion22 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Benign or Malignant Diseases With Indication for Laparoscopic or Robotic Colorectal ResectionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Model description
- Prospective, randomized controlled, open-label
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Byung Soh Min, Principal investigator, Severance Hospital, Yonsei University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969016
- Sponsor's protocol ID
- 4-2020-1023
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jan H, Waters N, Haines P, Kent A. LiquiBand(R) Surgical S topical adhesive versus sutures for the closure of laparoscopic wounds. A randomized controlled trial. Gynecol Surg. 2013;10(4):247-252. doi: 10.1007/s10397-013-0805-5. Epub 2013 Jul 10.
PubMed 24273476Dowson CC, Gilliam AD, Speake WJ, Lobo DN, Beckingham IJ. A prospective, randomized controlled trial comparing n-butyl cyanoacrylate tissue adhesive (LiquiBand) with sutures for skin closure after laparoscopic general surgical procedures. Surg Laparosc Endosc Percutan Tech. 2006 Jun;16(3):146-50. doi: 10.1097/00129689-200606000-00005.
PubMed 16804456Koonce SL, Eck DL, Shaddix KK, Perdikis G. A prospective randomized controlled trial comparing N-butyl-2 cyanoacrylate (Histoacryl), octyl cyanoacrylate (Dermabond), and subcuticular suture for closure of surgical incisions. Ann Plast Surg. 2015 Jan;74(1):107-10. doi: 10.1097/SAP.0b013e318289856f.
PubMed 24905134Fraeman KH, Reynolds MW, Vaughn BB, Hart JC. Patient outcomes associated with 2-octyl cyanoacrylate topical skin adhesive in coronary artery bypass graft surgery. Surg Infect (Larchmt). 2011 Aug;12(4):307-16. doi: 10.1089/sur.2010.062.
PubMed 21859334Bartenstein DW, Cummins DL, Rogers GS. A Prospective, Randomized, Single-Blind Study Comparing Cyanoacrylate Adhesives to Sutures for Wound Closure in Skin Cancer Patients. Dermatol Surg. 2017 Nov;43(11):1371-1378. doi: 10.1097/DSS.0000000000001200.
PubMed 28595249Malhotra V, Dayashankara Rao JK, Arya V, Sharma S, Singh S, Luthra P. Evaluating the use of octyl-2-cyanoacrylate in unilateral cleft lip repair. Natl J Maxillofac Surg. 2016 Jul-Dec;7(2):153-158. doi: 10.4103/0975-5950.201364.
PubMed 28356686Martin JG, Hollenbeck ST, Janas G, Makar RA, Pabon-Ramos WM, Suhocki PV, Miller MJ, Sopko DR, Smith TP, Kim CY. Randomized Controlled Trial of Octyl Cyanoacrylate Skin Adhesive versus Subcuticular Suture for Skin Closure after Implantable Venous Port Placement. J Vasc Interv Radiol. 2017 Jan;28(1):111-116. doi: 10.1016/j.jvir.2016.08.009. Epub 2016 Nov 9.
PubMed 27836404Chen CT, Choi CL, Suen DT, Kwong A. A prospective randomised controlled trial of octylcyanoacrylate tissue adhesive and standard suture for wound closure following breast surgery. Hong Kong Med J. 2016 Jun;22(3):216-22. doi: 10.12809/hkmj154513. Epub 2016 Apr 22.
PubMed 27101789Buchweitz O, Frye C, Moeller CP, Nugent W, Krueger E, Nugent A, Biel P, Juergens S. Cosmetic outcome of skin adhesives versus transcutaneous sutures in laparoscopic port-site wounds: a prospective randomized controlled trial. Surg Endosc. 2016 Jun;30(6):2326-31. doi: 10.1007/s00464-015-4474-5. Epub 2015 Oct 1.
PubMed 26428200Van Haute C, Tailly T, Klockaerts K, Ringoir Y. Sutureless circumcision using 2-Octyl cyanoacrylate results in more rapid and less painful procedures with excellent cosmetic satisfaction. J Pediatr Urol. 2015 Jun;11(3):147.e1-5. doi: 10.1016/j.jpurol.2015.02.013. Epub 2015 Mar 20.
PubMed 25910797Imbuldeniya AM, Rashid A, Murphy JP. A comparison of 2-octyl cyanoacrylate with nylon for wound closure of knee arthroscopy portals. J Wound Care. 2014 Sep;23(9):456-8, 460. doi: 10.12968/jowc.2014.23.9.456.
PubMed 25284299Ando M, Tamaki T, Yoshida M, Sasaki S, Toge Y, Matsumoto T, Maio K, Sakata R, Fukui D, Kanno S, Nakagawa Y, Yamada H. Surgical site infection in spinal surgery: a comparative study between 2-octyl-cyanoacrylate and staples for wound closure. Eur Spine J. 2014 Apr;23(4):854-62. doi: 10.1007/s00586-014-3202-5. Epub 2014 Feb 1.
PubMed 24487558Mudd CD, Boudreau JA, Moed BR. A prospective randomized comparison of two skin closure techniques in acetabular fracture surgery. J Orthop Traumatol. 2014 Sep;15(3):189-94. doi: 10.1007/s10195-013-0282-7. Epub 2013 Dec 31.
PubMed 24379118Soni A, Narula R, Kumar A, Parmar M, Sahore M, Chandel M. Comparing cyanoacrylate tissue adhesive and conventional subcuticular skin sutures for maxillofacial incisions--a prospective randomized trial considering closure time, wound morbidity, and cosmetic outcome. J Oral Maxillofac Surg. 2013 Dec;71(12):2152.e1-8. doi: 10.1016/j.joms.2013.08.029.
PubMed 24237777Julious SA, Owen RJ. A comparison of methods for sample size estimation for non-inferiority studies with binary outcomes. Stat Methods Med Res. 2011 Dec;20(6):595-612. doi: 10.1177/0962280210378945. Epub 2010 Oct 1.
PubMed 20889572
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Comparing Cyanoacrylate Skin Adhesive With Staple for Surgical Incision Closure After Laparoscopic / Robotic Bowel Resection
- ClinicalTrials.gov ID
- NCT04969016
- Acronym / sponsor ID
- 4-2020-1023
- Conditions
- Benign or Malignant Diseases With Indication for Laparoscopic or Robotic Colorectal Resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 22 Oct 2021 (estimated)
- Study completion
- 22 Oct 2021 (estimated)
- First posted
- 20 Jul 2021 (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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized controlled, open-label
| Arm | Type | Receives |
|---|---|---|
| LSA (liquid skin adhesive) | Experimental | Procedure: LSA (liquid skin adhesive)surgical wound closure with liquid skin adhesive (LiquiBand®) |
| Stapler | Active comparator | Procedure: staplersurgical wound closure with stapler |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| LSA (liquid skin adhesive)surgical wound closure with liquid skin adhesive (LiquiBand®) | Procedure or surgery | LSA (liquid skin adhesive) |
| staplersurgical wound closure with stapler | Procedure or surgery | Stapler |
Primary outcome
Total management time of surgical wound
Time frame: postoperative day 60
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.
2 secondary outcomes
Surgical wound related complication
Time frame: postoperative day 60
Total management costs of surgical wound
Time frame: postoperative day 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Background: PubMed 24273476Jan H, Waters N, Haines P, Kent A. LiquiBand(R) Surgical S topical adhesive versus sutures for the closure of laparoscopic wounds. A randomized controlled trial. Gynecol Surg. 2013;10(4):247-252. doi: 10.1007/s10397-013-0805-5. Epub 2013 Jul 10.
- Background: PubMed 16804456Dowson CC, Gilliam AD, Speake WJ, Lobo DN, Beckingham IJ. A prospective, randomized controlled trial comparing n-butyl cyanoacrylate tissue adhesive (LiquiBand) with sutures for skin closure after laparoscopic general surgical procedures. Surg Laparosc Endosc Percutan Tech. 2006 Jun;16(3):146-50. doi: 10.1097/00129689-200606000-00005.
- Background: PubMed 24905134Koonce SL, Eck DL, Shaddix KK, Perdikis G. A prospective randomized controlled trial comparing N-butyl-2 cyanoacrylate (Histoacryl), octyl cyanoacrylate (Dermabond), and subcuticular suture for closure of surgical incisions. Ann Plast Surg. 2015 Jan;74(1):107-10. doi: 10.1097/SAP.0b013e318289856f.
- Background: PubMed 21859334Fraeman KH, Reynolds MW, Vaughn BB, Hart JC. Patient outcomes associated with 2-octyl cyanoacrylate topical skin adhesive in coronary artery bypass graft surgery. Surg Infect (Larchmt). 2011 Aug;12(4):307-16. doi: 10.1089/sur.2010.062.
- Background: PubMed 28595249Bartenstein DW, Cummins DL, Rogers GS. A Prospective, Randomized, Single-Blind Study Comparing Cyanoacrylate Adhesives to Sutures for Wound Closure in Skin Cancer Patients. Dermatol Surg. 2017 Nov;43(11):1371-1378. doi: 10.1097/DSS.0000000000001200.
- Background: PubMed 28356686Malhotra V, Dayashankara Rao JK, Arya V, Sharma S, Singh S, Luthra P. Evaluating the use of octyl-2-cyanoacrylate in unilateral cleft lip repair. Natl J Maxillofac Surg. 2016 Jul-Dec;7(2):153-158. doi: 10.4103/0975-5950.201364.
- Background: PubMed 27836404Martin JG, Hollenbeck ST, Janas G, Makar RA, Pabon-Ramos WM, Suhocki PV, Miller MJ, Sopko DR, Smith TP, Kim CY. Randomized Controlled Trial of Octyl Cyanoacrylate Skin Adhesive versus Subcuticular Suture for Skin Closure after Implantable Venous Port Placement. J Vasc Interv Radiol. 2017 Jan;28(1):111-116. doi: 10.1016/j.jvir.2016.08.009. Epub 2016 Nov 9.
- Background: PubMed 27101789Chen CT, Choi CL, Suen DT, Kwong A. A prospective randomised controlled trial of octylcyanoacrylate tissue adhesive and standard suture for wound closure following breast surgery. Hong Kong Med J. 2016 Jun;22(3):216-22. doi: 10.12809/hkmj154513. Epub 2016 Apr 22.
- Background: PubMed 26428200Buchweitz O, Frye C, Moeller CP, Nugent W, Krueger E, Nugent A, Biel P, Juergens S. Cosmetic outcome of skin adhesives versus transcutaneous sutures in laparoscopic port-site wounds: a prospective randomized controlled trial. Surg Endosc. 2016 Jun;30(6):2326-31. doi: 10.1007/s00464-015-4474-5. Epub 2015 Oct 1.
- Background: PubMed 25910797Van Haute C, Tailly T, Klockaerts K, Ringoir Y. Sutureless circumcision using 2-Octyl cyanoacrylate results in more rapid and less painful procedures with excellent cosmetic satisfaction. J Pediatr Urol. 2015 Jun;11(3):147.e1-5. doi: 10.1016/j.jpurol.2015.02.013. Epub 2015 Mar 20.
- Background: PubMed 25284299Imbuldeniya AM, Rashid A, Murphy JP. A comparison of 2-octyl cyanoacrylate with nylon for wound closure of knee arthroscopy portals. J Wound Care. 2014 Sep;23(9):456-8, 460. doi: 10.12968/jowc.2014.23.9.456.
- Background: PubMed 24487558Ando M, Tamaki T, Yoshida M, Sasaki S, Toge Y, Matsumoto T, Maio K, Sakata R, Fukui D, Kanno S, Nakagawa Y, Yamada H. Surgical site infection in spinal surgery: a comparative study between 2-octyl-cyanoacrylate and staples for wound closure. Eur Spine J. 2014 Apr;23(4):854-62. doi: 10.1007/s00586-014-3202-5. Epub 2014 Feb 1.
- Individual participant dataSharing planned: No
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.
Byung Soh Min principal investigator
Severance Hospital, Yonsei University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LSA (liquid skin adhesive) and stapler in people with Benign or Malignant Diseases With Indication for Laparoscopic or Robotic Colorectal Resection, run by Yonsei University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Byung Soh Min (82-10-7677-5679, BSMIN@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total management time of surgical wound (time frame: postoperative day 60). 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 NCT04969016, which also lists 15 linked publications.
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 20 Jul 2021; AzTrials last refreshed its copy on 3 Nov 2026.