Study of DERMABOND ProPen in Closure of Colectomy Wounds
Primary Purpose
Wound
Status
Terminated
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Dermabond ProPen (2-octylcyanoacrylate)
Skin closure with skin staples
Sponsored by
About this trial
This is an interventional treatment trial for Wound focused on measuring Colectomy, Closure, Wound, Dermabond, Propen
Eligibility 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
Sites / Locations
- Singapore General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Skin Staples
Dermabond
Arm Description
Skin closure with skin staples
Closure of abdominal wound with dermabond (2-octylcyanoacrylate)
Outcomes
Primary Outcome Measures
Wound healing
Patient satisfaction
Secondary Outcome Measures
Superficial surgical site infections
Time taken for wound closure
Full Information
NCT ID
NCT00978133
First Posted
September 14, 2009
Last Updated
April 16, 2018
Sponsor
Singapore General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00978133
Brief Title
Study of DERMABOND ProPen in Closure of Colectomy Wounds
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 Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in accrual of study subjects, small numbers of potential subjects
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound
Keywords
Colectomy, Closure, Wound, Dermabond, Propen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Skin Staples
Arm Type
Active Comparator
Arm Description
Skin closure with skin staples
Arm Title
Dermabond
Arm Type
Experimental
Arm Description
Closure of abdominal wound with dermabond (2-octylcyanoacrylate)
Intervention Type
Procedure
Intervention Name(s)
Dermabond ProPen (2-octylcyanoacrylate)
Other Intervention Name(s)
Dermabond ProPen
Intervention Description
Application of 2 layers of Dermabond to abdominal wounds after closure of deep layers
Intervention Type
Procedure
Intervention Name(s)
Skin closure with skin staples
Intervention Description
Skin closure with skin staples
Primary Outcome Measure Information:
Title
Wound healing
Time Frame
3 months
Title
Patient satisfaction
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Superficial surgical site infections
Time Frame
3 months
Title
Time taken for wound closure
Time Frame
Intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian KP Ong, FRCSEd
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kok-Sun Ho, FRCS
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
9832658
Citation
Quinn J, Wells G, Sutcliffe T, Jarmuske M, Maw J, Stiell I, Johns P. Tissue adhesive versus suture wound repair at 1 year: randomized clinical trial correlating early, 3-month, and 1-year cosmetic outcome. Ann Emerg Med. 1998 Dec;32(6):645-9. doi: 10.1016/s0196-0644(98)70061-7.
Results Reference
background
PubMed Identifier
15450839
Citation
Blondeel PN, Murphy JW, Debrosse D, Nix JC 3rd, Puls LE, Theodore N, Coulthard P. Closure of long surgical incisions with a new formulation of 2-octylcyanoacrylate tissue adhesive versus commercially available methods. Am J Surg. 2004 Sep;188(3):307-13. doi: 10.1016/j.amjsurg.2004.04.006.
Results Reference
background
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Study of DERMABOND ProPen in Closure of Colectomy Wounds
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