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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)
Information provided by:
Singapore General Hospital Identifier:
First received: September 14, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
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
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.

Resource links provided by NLM:

Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Wound healing [ Time Frame: 3 months ]
  • Patient satisfaction [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Superficial surgical site infections [ Time Frame: 3 months ]
  • Time taken for wound closure [ Time Frame: Intraoperative ]

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


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00978133

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

Responsible Party: Dr Ong Kian Peng, Julian, Singapore General Hospital, Department of Colorectal Surgery Identifier: NCT00978133     History of Changes
Other Study ID Numbers: Dermabond colectomy wounds
Study First Received: September 14, 2009
Last Updated: September 14, 2009

Keywords provided by Singapore General Hospital:

Additional relevant MeSH terms:
Wounds and Injuries processed this record on August 16, 2017