Study of DERMABOND ProPen in Closure of Colectomy Wounds

Wound Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00978133
• Other study ID #: Dermabond colectomy wounds
• Status: Terminated
• Phase: Phase 2
• First received: September 14, 2009
• Last updated: April 16, 2018
• Start date: May 2006
• Est. completion date: May 2007

Study information

• Verified date: April 2018
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 74
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound
• Wounds and Injuries

Intervention

Procedure:
• Dermabond ProPen (2-octylcyanoacrylate)
Application of 2 layers of Dermabond to abdominal wounds after closure of deep layers
• Skin closure with skin staples
Skin closure with skin staples

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing		3 months
Primary	Patient satisfaction		3 months
Secondary	Superficial surgical site infections		3 months
Secondary	Time taken for wound closure		Intraoperative