Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05744284 |
| Other study ID # |
IDC-001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2016 |
| Est. completion date |
December 20, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
University of Catania |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The use of electrocautery to incise the skin is still debated. Aim of the present study is to
contribute at the use of electrocautery for skin incision as safe procedure both for patients
and surgeons.
Description:
All patients observed between 2016 and 2021 at the Department of Surgical Sciences, Organ
Transplantation, and Advanced Technologies of University of Catania and submitted to
abdominal surgery in which the incision of the skin have been done by electrocautery, have
been considered. Sex, age, kind of disease in relation to the organ affected and type of
surgical procedure and related incision have been investigated. Patients with diabetes
mellitus, coagulation disorders and those submitted to a treatment of steroids and
anticoagulant; patients previously operated with scar in the site of the second operations,
or with anemia or with active source of infection in any part of the body where excluded from
the study.
The ethical approval isn't necessary because is a retrospective study. All patients have
express the oral informed consent to participate at this study.
In this retrospective study was analyzed the skin incision that has been classified into
laparotomic or laparoscopic, in elective or emergency surgery. The laparotomic included large
(large midline as xipho-umbilical or umbilical pubic incision, subcostals or pararectal) and
small (small midline no more than 7 cm, inguinal, McBurney) skin incisions. The laparoscopic
on the opposite involve incisions from minimum of 1 cm or less for introduction of trocars,
and a maximum of 10 cm to extract organ. The subcutaneous layer has been closed using an
interrupted suture using Vycril®3-0 on the opposite the skin suture has been done using
metallic clips.
All patients have been submitted to general or spinal anesthesia. Antibiotic prophylaxis was
done, following the guidelines related to the disease (5). Patients submitted to hernioplasty
of laparoscopic cholecystectomy or any procedure in which the literature have reached a
consensus any antibiotic treatment including the prophylaxis have not been done (5).
The outcomes considered are wound infections, post-operative pain, healing time, cosmetic
results. The post operative pain has been related to the administration of paracetamole 1 gr
every 12 hours for the first 3 days. The healing time and cosmetic results have been
evaluated both during the hospitalization or in the out patients clinics, after 10 from
surgical procedure at moment of ablation of metallic clips, and/or 20 days after the surgical
incision with final clinical evaluations of the scar. Finally considering the medical records
and operative reports, patients were contacted 6 months later by phone by resident in surgery
ask them to evaluate their scar. The patient was asks simple to define their scar as
acceptable and consequently patient satisfied or not acceptable so patient not satisfied.
We, also, consider the reported injury to surgeons or theater workers during the surgical
procedure. Particularly we have reported the burns from hole in the gloves related to an
absent respect of the isolated generator circuit
All patients were treat an expert surgeon, that used the same technique for the incision
skin.
The skin incision has been done using the following rules: the cutting diathermy have been
used to incise the skin. If bleeding comes from the dermis, the coagulation diathermy has
been shortly used using the tip of the headpiece, without forceps. To incise the skin we have
used a Valleylab force TX Medtronic Italy equipped with standard diathermy pen electrode, set
on cutting mode for skin at 20 KHz sinusoidal current and on coagulation mode at K40 Hz both
for skin and for deeper tissues (6).
Electrosurgery works by electrons' handling on living tissue using an alternating current
density sufficient to create heat within tissue cells to destroy them.
It is mandatory to consider the mode of use electrosurgery. In the cutting mode, a continuous
current produce extreme heat causing vaporization so the conversion of the cells into steam.
When we use the electrosurgery unit into cutting mode for the skin the cells vaporize and the
tissue is divided with a minimum devitalization, the thermal damage is minimal and it is not
propagated to neighboring cells. Differently the coagulation mode that cause high thermal
damage and necrosis of adjacent cells.
