Study of DERMABOND ProPen in Closure of Colectomy Wounds

This study has been terminated.
(Difficulty in accrual of study subjects, small numbers of potential subjects)
Sponsor:
Information provided by:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT00978133
First received: September 14, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Wound
Procedure: Dermabond ProPen (2-octylcyanoacrylate)
Procedure: Skin closure with skin staples
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Study to Evaluate the Use of DERMABOND ProPen (2-octylcyanoacrylate) in the Closure of Abdominal Wounds Versus Closure With Skin Staples in Patients Undergoing Elective Colectomy.

Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Wound healing [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Superficial surgical site infections [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Time taken for wound closure [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: May 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Skin Staples
Skin closure with skin staples
Procedure: Skin closure with skin staples
Skin closure with skin staples
Experimental: Dermabond
Closure of abdominal wound with dermabond (2-octylcyanoacrylate)
Procedure: Dermabond ProPen (2-octylcyanoacrylate)
Application of 2 layers of Dermabond to abdominal wounds after closure of deep layers
Other Name: Dermabond ProPen

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978133

Locations
Singapore
Singapore General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
Investigators
Principal Investigator: Julian KP Ong, FRCSEd Singapore General Hospital
Principal Investigator: Kok-Sun Ho, FRCS Singapore General Hospital
  More Information

Publications:
Responsible Party: Dr Ong Kian Peng, Julian, Singapore General Hospital, Department of Colorectal Surgery
ClinicalTrials.gov Identifier: NCT00978133     History of Changes
Other Study ID Numbers: Dermabond colectomy wounds
Study First Received: September 14, 2009
Last Updated: September 14, 2009
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by Singapore General Hospital:
Colectomy
Closure
Wound
Dermabond
Propen

ClinicalTrials.gov processed this record on August 20, 2014