Electrocautery for Safe Skin Incision

NCT05744284 | Completed FDA Device

• 1 other identifier: IDC-001
• Study Type: observational
• Target: 281
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Injury

Keywords

Electrocautery; scalpel

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  6 months after surgery

Study Arms (1)

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.

Device: electrocautery

Interventions

electrocautery DEVICE

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

Sex, age, kind of disease in relation to the organ affected

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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%).

You may qualify if:

• surgical procedure with electrocautery skin incision

You may not qualify if:

• previews scars
• infections
• anemia

Sponsors & Collaborators

• University of Catania: lead

Study Sites (1)

Isidoro Di carlo

Catania, CT, 95126, Italy

Location

MeSH Terms

Interventions

Electrocoagulation

Intervention Hierarchy (Ancestors)

Cautery; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: February 24, 2023
• Study Start: January 1, 2016
• Primary Completion: November 15, 2021
• Study Completion: December 20, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

IT (1)