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Study of DERMABOND ProPen in Closure of Colectomy Wounds

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.

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00978133
Enrollment
74
Registered
2009-09-16
Start date
2006-05-31
Completion date
2007-05-31
Last updated
2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound

Keywords

Colectomy, Closure, Wound, Dermabond, Propen

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.

Interventions

PROCEDUREDermabond ProPen (2-octylcyanoacrylate)

Application of 2 layers of Dermabond to abdominal wounds after closure of deep layers

PROCEDURESkin closure with skin staples

Skin closure with skin staples

Sponsors

Singapore General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Wound healing3 months
Patient satisfaction3 months

Secondary

MeasureTime frame
Superficial surgical site infections3 months
Time taken for wound closureIntraoperative

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026