NCT00978133

Brief Summary

2-octylcyanoacrylate (2-OCA) has been used extensively in clinical practice in trauma, plastic surgery, orthopaedic surgery, emergency medicine and paediatrics. Most studies on 2-OCA to date have focused on closure of short wounds, and only one has included closure of abdominal wounds in the context of general surgery. Here, the investigators will look at the results of closure of abdominal wounds in patients undergoing elective colectomies with 2-OCA, which is commercially available to us, versus closure with skin staples, which is the current standard technique of skin closure employed in the Department of Colorectal Surgery, Singapore General Hospital. The primary objective was to measure effectiveness of 2-OCA in 2 respects - the adequacy of wound healing and cosmesis, and the incidence of superficial wound infection.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2009

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

September 14, 2009

Last Update Submit

April 16, 2018

Conditions

Wound

Keywords

ColectomyClosureWoundDermabondPropen

Outcome Measures

Primary Outcomes (2)

  • Wound healing

    3 months

  • Patient satisfaction

    3 months

Secondary Outcomes (2)

  • Superficial surgical site infections

    3 months

  • Time taken for wound closure

    Intraoperative

Study Arms (2)

Skin Staples

ACTIVE COMPARATOR

Skin closure with skin staples

Procedure: Skin closure with skin staples

Dermabond

EXPERIMENTAL

Closure of abdominal wound with dermabond (2-octylcyanoacrylate)

Procedure: Dermabond ProPen (2-octylcyanoacrylate)

Interventions

Dermabond ProPen (2-octylcyanoacrylate)PROCEDURE

Application of 2 layers of Dermabond to abdominal wounds after closure of deep layers

Also known as: Dermabond ProPen
Dermabond
Skin closure with skin staplesPROCEDURE

Skin closure with skin staples

Skin Staples

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective colectomies for benign or malignant conditions
  • Midline vertical incisions or skin crease incisions
  • Above the age of 21 years old
  • Able to make own valid informed decisions

You may not qualify if:

  • Patients undergoing surgery for recurrent or metastatic disease
  • Surgery for surgical emergencies such as acute abdomen or bleeding
  • Known allergy to DERMABOND ProPen Tissue Adhesive or any of its constituents (cyanoacrylate or formaldehyde)
  • Patients on immunosuppression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (2)

  • Quinn J, Wells G, Sutcliffe T, Jarmuske M, Maw J, Stiell I, Johns P. Tissue adhesive versus suture wound repair at 1 year: randomized clinical trial correlating early, 3-month, and 1-year cosmetic outcome. Ann Emerg Med. 1998 Dec;32(6):645-9. doi: 10.1016/s0196-0644(98)70061-7.

    PMID: 9832658BACKGROUND

  • Blondeel PN, Murphy JW, Debrosse D, Nix JC 3rd, Puls LE, Theodore N, Coulthard P. Closure of long surgical incisions with a new formulation of 2-octylcyanoacrylate tissue adhesive versus commercially available methods. Am J Surg. 2004 Sep;188(3):307-13. doi: 10.1016/j.amjsurg.2004.04.006.

    PMID: 15450839BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Interventions

octyl 2-cyanoacrylate

Study Officials

  • Julian KP Ong, FRCSEd

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

  • Kok-Sun Ho, FRCS

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2009

First Posted

September 16, 2009

Study Start

May 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations

SG(1)