Study of DERMABOND ProPen in Closure of Colectomy Wounds

Phase 2

Terminated

• Conditions: Wound
• Interventions: Procedure: Dermabond ProPen (2-octylcyanoacrylate); Procedure: Skin closure with skin staples

• Registration Number: NCT00978133
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Study First Submitted: 2009-09-14
• Study First Submitted QC: 2009-09-14
• Study First Posted: 2009-09-16
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dermabond	Dermabond ProPen (2-octylcyanoacrylate)	Closure of abdominal wound with dermabond (2-octylcyanoacrylate)
Skin Staples	Skin closure with skin staples	Skin closure with skin staples

Primary Outcome Measures

Name	Time	Method
Wound healing	3 months
Patient satisfaction	3 months

Secondary Outcome Measures

Name	Time	Method
Time taken for wound closure	Intraoperative
Superficial surgical site infections	3 months

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore