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Study of DERMABOND ProPen in Closure of Colectomy Wounds

S

Singapore Health Services (SingHealth)

Status and phase

Terminated
Phase 2

Conditions

Wound

Treatments

Procedure: Dermabond ProPen (2-octylcyanoacrylate)
Procedure: Skin closure with skin staples

Study type

Interventional

Funder types

Other

Identifiers

NCT00978133
Dermabond colectomy wounds

Details and patient eligibility

About

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.

Enrollment

74 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

74 participants in 2 patient groups

Skin Staples
Active Comparator group
Description:
Skin closure with skin staples
Treatment:
Procedure: Skin closure with skin staples
Dermabond
Experimental group
Description:
Closure of abdominal wound with dermabond (2-octylcyanoacrylate)
Treatment:
Procedure: Dermabond ProPen (2-octylcyanoacrylate)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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