Study of DERMABOND ProPen in Closure of Colectomy Wounds

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Wound

Intervention / Treatment
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* Procedure: Dermabond ProPen (2-octylcyanoacrylate)
* Procedure: Skin closure with skin staples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Skin Staples<br>Skin closure with skin staples | Procedure: Skin closure with skin staples<br>* Skin closure with skin staples<br>|
| Experimental: Dermabond<br>Closure of abdominal wound with dermabond (2-octylcyanoacrylate) | Procedure: Dermabond ProPen (2-octylcyanoacrylate)<br>* Application of 2 layers of Dermabond to abdominal wounds after closure of deep layers<br>* Other names: Dermabond ProPen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing |  | 3 months | 
| Patient satisfaction |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superficial surgical site infections |  | 3 months | 
| Time taken for wound closure |  | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colectomy, Closure, Wound, Dermabond, Propen