Study of DERMABOND ProPen in Closure of Colectomy Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00978133
Recruitment Status : Terminated (Difficulty in accrual of study subjects, small numbers of potential subjects)
First Posted : September 16, 2009
Last Update Posted : April 18, 2018
Information provided by (Responsible Party):
Singapore General Hospital

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : May 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Wound healing [ Time Frame: 3 months ]
  2. Patient satisfaction [ Time Frame: 3 months ]

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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