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Randomised controlled double blinded trial of the use of cold scalpel versus cutting diathermy for skin incisions in clean (non-bowel) laparoscopic and open surgery

Randomised controlled double blinded trial comparing cosmesis and wound healing of skin incisions in clean (non-bowel) laparoscopic and open surgery using cold scalpel versus cutting diathermy

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000567224
Enrollment
100
Registered
2009-07-10
Start date
2009-08-03
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The skin incisions to perform common surgical procedures can be made using a traditional steel knife blade (cold scalpel) or “electric knife” (cutting diathermy), which is a blunt electrode transmitting electric current to divide the skin. Despite both these methods being in use for many years, to date we have found very little convincing evidence that one is better than the other. Thus the choice of method used is often made on surgeon preference alone. Some surgeons are using both methods interchangeably in routine practice. We are conducting a trial which aims to determine whether one modality is superior to the other in terms of wound healing and infection. In this era of increasing awareness and prevention of blood-borne infection transmission, alternatives to the use of sharp instruments such as the traditional cold scalpel are continually being sought. If both methods are shown to produce similar results, the blunt cutting diathermy could provide a much safer alternative to the traditional sharp cold scalpel.

Interventions

Skin incisions made using a flat, blunt-tipped stainless steel diathermy blade transmitting 30W pure cutting current. Cutting effect is produced by vapourising cells. Procedure requires only a few seconds.

Sponsors

Alfred Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult patients presenting to a single surgeon's rooms who are subsequently booked for elective clean (non-bowel) laparoscopic or open surgery (by the same surgeon)

Exclusion criteria

malignancy; connective tissue disease; immunocompromised patients; diabetes mellitus; bleeding disorders; previous history of keloid/hypertrophic; scarring; existing skin disease, open wounds on abdomen; previous surgical wound infection following abdominal surgery; obesity - defined as Body Mass Index (BMI) greater than 35; smoking

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026