Advertisement

Topics

Cutaneous Scarring of Scalpel Versus Cautery

2014-07-24 14:15:03 | BioPortfolio

Summary

Cutaneous scarring after elective surgery is a concern for surgeons of all types, perhaps even more so to plastic surgeons. Cautery is often used on the "cut" setting to make or extend incisions; however very few studies have looked at the results of these scars. The investigators' study aims are to compare standard scalpel incisions versus cautery incisions and to objectively compare the resultant scars in a prospective, randomized, controlled fashion.

Description

Rationale: Most surgeons at some point have used the "cut" setting on a cautery device to make or extend an incision. Anecdotally, there does not appear to be a noticeable difference in the scarring. This opinion, however is not shared by all surgeons.

Review of the literature reveals a paucity of evidence supporting the use of cutting cautery vs. standard, scalpel incision. A study that objectively, prospectively, and randomly compares the scars between these two methods has the potential to alter the doctrine of scalpel incisions, potentially saving money, and allowing a safer operating room environment (one free of scalpels in some cases).

Objectives: To objectively compare the cutaneous scars resulting from scalpel versus cutting cautery incisions using a subjective and objective scar measurement tool.

Methodology:

Research Design: This study will be a Blinded, Prospective, Randomized Controlled Trial.

Research Participants:

Comparison Information: The patient will have ½ of the incision performed with standard scalpel incision, and the contralateral ½ of the incision with cutting cautery incision. The sides will be randomized using a random number generator. For purposes of this study, the right side of the incision is defined as the patient's right side and the left side of the incision is defined as the patient's left side.

Criteria for Discontinuation: The study will be discontinued if it becomes obvious that the cautery ½ of the incision develops increased complications relating to infections, wound breakdown, or scarring.

Observations: The patients will follow up after surgery for evaluations at 2 weeks, 3 months, 6 months, and 12 months. Patients, physicians and a blinded independent observer will evaluate the scars using a visual analogue scale at 2 weeks, 3 months, 6 months and 12 months. Also, at 12 months, the Patient and Observer Scar Assessment Tool will be used to evaluate all scars in order to provide objective and subjective scar evaluation. The subject, surgeon and blinded observer will complete this evaluation.

Sample Size: 10 patients will be enrolled in our study. The data gathered from this pilot study should provide us with the data necessary to perform a power and sample size calculation for a future randomized controlled trial.

Date Management and Analysis: At postoperative follow up visits (2 weeks +/- 4 days, 3 months +/- 2 weeks, 6 months +/- 2 weeks), the patient, physician and independent observer will evaluate the scar subjectively using a visual analogue scale measuring 10 cm in length. One side of the scale (the side nearest 0) will imply the poorest scar imaginable; the opposite side will represent the best. Measurements will be taken regarding width, and observations regarding erythema and pigment will be noted.

At the 12 month postoperative follow up, the Patient and Observer Scar Assessment Tool will be used to compare the scars in order to provide both subjective and objective data.

Ethical Considerations

Protection of Human Subjects: Approval from the IRB will be obtained prior to beginning this study. All investigators have met federal and institutional educational requirements for Human Subjects Protection.

Patients will be offered scar revisions at no additional costs to the patient on the "test" side. These scar revisions will be offered at 1 year if necessary.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Scars

Intervention

Cautery vs Active Control Arm (Scalpel)

Location

Scott and White Hospital and Clinic
Temple
Texas
United States
76508

Status

Recruiting

Source

Scott and White Hospital & Clinic

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:15:03-0400

Clinical Trials [478 Associated Clinical Trials listed on BioPortfolio]

A Randomized Controlled Trial of Three Vasectomy Techniques

This study will be a randomized, controlled multicenter trial, conducted jointly by the Indian Council of Medical Research, New Delhi and Family Health International, which will compare th...

Thermal Micro-cautery for Painful Knee Osteoarthritis

To trial a traditional pain management technique from Ayurveda in a modern way - the technique involves micro - cautery to painful areas in knee osteoarthritis for patients on a waiting li...

Use of the Harmonic Scalpel in Neck Dissection

Neck dissection is the main technique used by head and neck surgeons to treat known or suspected metastatic cancer to the neck. The traditional radical neck dissection was effective at tr...

Thyroid Surgery With the New Harmonic Scalpel: a Prospective Randomized Study

The objective of this study is to compare the results of total thyroidectomy using the new harmonic scalpel device (FOCUS) to that with the previously available harmonic scalpel device (HA...

Use of Harmonic Scalpel to Decrease Lymphatic and Chest Tube Drainage After Lymph Node Dissection With Lobectomy.

In an effort to elucidate whether the Harmonic Scalpel will improve sealing lymphatics and decrease lymphatic drainage thereby decreasing the length of time that chest tubes are required a...

PubMed Articles [12393 Associated PubMed Articles listed on BioPortfolio]

Comparison of Electrosurgical Devices for Cervical Conization: Novel Monopolar Scalpel (VIO) Versus Ultrasonic Scalpel.

The aim of this study was to compare the outcomes associated with the use of a novel monopolar scalpel with those associated with the use of an ultrasonic scalpel for cervical conization of cervical i...

A histological evaluation of the surgical margins from human oral fibrous-epithelial lesions excised with CO2 laser, Diode laser, Er:YAG laser, Nd:YAG laser, electrosurgical scalpel and cold scalpel.

We aim to evaluate the presence of histological artefacts in the surgical margins of human oral fibro-epithelial hyperplasias excised with lasers of different wavelengths, and also electrosurgical sca...

Effectiveness of subcision using carboxytherapy plus fractional carbon dioxide laser resurfacing in the treatment of atrophic acne scars: Comparative split face study.

fractional carbon dioxide laser resurfacing is the gold standard treatment for atrophic acne scars but when combined with subcision to the depressed scars it provides rapid improvement. Carboxytherapy...

Effectiveness of harmonic scalpel in patients submitted to total thyroidectomy: systematic review with meta-analysis.

The objective of this study was to evaluate the efficacy and safety of the harmonic scalpel compared to the conventional technique in patients submitted to total thyroidectomy.

Penile reconstruction in a newborn following complicated circumcision: A case report.

Grade V post-circumcision penile injury is known as "total phallic loss". It is usually seen with the use of mono-polar electro-cautery for circumcision resulting in penile necrosis. We report on a ne...

Medical and Biotech [MESH] Definitions

The application of a caustic substance, a hot instrument, an electric current, or other agent to control bleeding while removing or destroying tissue.

Use of a non-cautery–dependent mechanical device that simultaneously cuts and aspirates polyp and/or myoma tissue.

Procedures using an electrically heated wire or scalpel to treat hemorrhage (e.g., bleeding ulcers) and to ablate tumors, mucosal lesions, and refractory arrhythmias. It is different from ELECTROSURGERY which is used more for cutting tissue than destroying and in which the patient is part of the electric circuit.

Work consisting of a clinical trial involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicine, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trial is characterized as a RANDOMIZED CONTROLLED TRIAL.

Clinical trials involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicines, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trials are characterized as RANDOMIZED CONTROLLED TRIALS AS TOPIC.

More From BioPortfolio on "Cutaneous Scarring of Scalpel Versus Cautery"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...


Searches Linking to this Trial