Skin InjuryNCT05744284
Electrocautery for Safe Skin Incision
An observational study of Skin Injury, run by University of Catania at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Skin Injury
- What is being tested?
- electrocautery
- Type of treatment
- Medical device
- How many people
- 281 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2016to 20 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 years
- All sexes
- Child, Adult
Study population: A total of 281 patients (119 females, 162 males) with a median age of 60 years were scheduled for abdominal surgery. Most of the patients have submitted to surgical procedures involving the small and large intestine (160 patients, 56.9%). Others patients were operated for liver, gallbladder, spleen or pancreas (41 patients, 14.5%), esophagus stomach or duodenum (4 patients, 1.4%) disease. Finally, some patients undergone to hernioplasty (57 patients, 20.2%). And at the least we have grouped as miscellaneous some patients undergoing procedures that concerned the subcutaneous or unspecified (19 patients, 6.7%).
Who may be able to join
- surgical procedure with electrocautery skin incision
Who cannot join
- previews scars
- infections
- anemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: It is Time to Change Method of Skin Incision From Scalpel to Electrocautery.
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.
Read the detailed 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.
- Conditions
- Skin Injury
- Being tested
- electrocautery
- Keywords
- Electrocautery, scalpel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrocauteryDevice
advantages reported in this study in terms of wound infections, healing time, postoperative pain and cosmetic results in association with economic gain for saving in the purchase of scalpels, represent a formidable motivation for the surgeons to abandon the scalpel in favors of diathermy
| Study group | Role | What they receive |
|---|---|---|
| Sex, age, kind of disease in relation to the organ affected | 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. Receives: Device: electrocautery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound infections
The wound infections were recorded in patients undergoing emergency surgery with laparotomic incisions. As sign of infection were observed fever, pain, hyperaemia and presence of pus.
Measured: 10 days
Post-operative pain
Patients refer pain classified as 1-2 in a numerical rating scale from 0 to 10, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.
Measured: 24 hours after procedures
Cosmetic results
The patient was asked simple to define their scar as acceptable and consequently patient satisfied or not acceptable so patient not satisfied.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 Jan 2016
- Primary completion15 Nov 2021
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isidoro Di Carlo, MD, PhD, FACS, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744284
- Sponsor's protocol ID
- IDC-001
- Status last verified
- Feb 2023
- First submitted
- 28 Jan 2023
- Last updated
- 24 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- It is Time to Change Method of Skin Incision From Scalpel to Electrocautery.
- ClinicalTrials.gov ID
- NCT05744284
- Acronym / sponsor ID
- IDC-001
- Conditions
- Skin Injury
- Keywords
- Electrocautery, scalpel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sex, age, kind of disease in relation to the organ affected | – | Device: electrocauterySex, 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. |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- A total of 281 patients (119 females, 162 males) with a median age of 60 years were scheduled for abdominal surgery. Most of the patients have submitted to surgical procedures involving the small and large intestine (160 patients, 56.9%). Others patients were operated for liver, gallbladder, spleen or pancreas (41 patients, 14.5%), esophagus stomach or duodenum (4 patients, 1.4%) disease. Finally, some patients undergone to hernioplasty (57 patients, 20.2%). And at the least we have grouped as miscellaneous some patients undergoing procedures that concerned the subcutaneous or unspecified (19 patients, 6.7%).
Key inclusion criteria (1 listed)
- surgical procedure with electrocautery skin incision
Key exclusion criteria (3 listed)
- previews scars
- infections
- anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrocauteryadvantages reported in this study in terms of wound infections, healing time, postoperative pain and cosmetic results in association with economic gain for saving in the purchase of scalpels, represent a formidable motivation for the surgeons to abandon the scalpel in favors of diathermy | Device | Sex, age, kind of disease in relation to the organ affected |
Primary outcome
Wound infections
Time frame: 10 days
The wound infections were recorded in patients undergoing emergency surgery with laparotomic incisions. As sign of infection were observed fever, pain, hyperaemia and presence of pus.
Post-operative pain
Time frame: 24 hours after procedures
Patients refer pain classified as 1-2 in a numerical rating scale from 0 to 10, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.
Cosmetic results
Time frame: 6 months after surgery
The patient was asked simple to define their scar as acceptable and consequently patient satisfied or not acceptable so patient not satisfied.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Injury, run by University of Catania at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound infections (time frame: 10 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.