Clinical trial NCT00978133: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Wound
Keywords: Colectomy
Closure
Wound
Dermabond
Propen
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2009-09-16
Enrollment: 74
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Wound healing
timeFrame: 3 months
measure: Patient satisfaction
timeFrame: 3 months
Secondary outcomes:
measure: Superficial surgical site infections
timeFrame: 3 months
measure: Time taken for wound closure
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Julian KP Ong, FRCSEd
role: PRINCIPAL_INVESTIGATOR
affiliation: Singapore General Hospital
name: Kok-Sun Ho, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.