Study of DERMABOND ProPen in Closure of Colectomy Wounds

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Skin Staples

Skin closure with skin staples

Group Type ACTIVE_COMPARATOR

Skin closure with skin staples

Intervention Type PROCEDURE

Skin closure with skin staples

Dermabond

Closure of abdominal wound with dermabond (2-octylcyanoacrylate)

Group Type EXPERIMENTAL

Dermabond ProPen (2-octylcyanoacrylate)

Intervention Type PROCEDURE

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

Interventions

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Dermabond ProPen (2-octylcyanoacrylate)

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

Intervention Type PROCEDURE

Skin closure with skin staples

Intervention Type PROCEDURE

Other Intervention Names

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Dermabond ProPen

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes