Cutaneous Scarring of Scalpel Versus Cautery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study Comparing Cutaneous Scarring When Scalpel Versus Cautery is Used to Make Skin Incisions

Conditions
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Scars

Intervention / Treatment
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* Procedure: Cautery vs Active Control Arm (Scalpel)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria: Patients undergoing primary, elective panniculectomy. Patients must voluntarily be enrolled in the study after informed consent. Patients must be in relative good health and have adequate nutrition. Patients of all races and genders will be included. Patients must agree to refrain from the use of topical scar products during the study period. Exclusion Criteria: Under the age of 18 years old Patients with previous history of hypertrophic or keloid scarring Patients presenting for scar revision Patients presenting for a non-elective surgery Patients with chronic immunosuppression or wound healing problems Currently taking medications that interfere with wound healing such as corticosteroids, anti-coagulants (aspirin or NSAIDs), vasoconstricting agents (adrenaline or ergotrate), anti-cancer drugs, or colchicine for gout, Use of any tobacco products

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cautery Arm<br>Cautery to make skin incision | Procedure: Cautery vs Active Control Arm (Scalpel)<br>* Interventions: The cautery used will be the standard operating room monopolar cautery used at our institution. The cautery will be used on a cut setting of 20 with a blend setting of zero (pure cut). A standard protected needle tip cautery will be used. A #15 blade carbon steel scalpel blade will be used on ½ of the incision; a cautery device with the above-mentioned settings will be used on the other ½ of the wound. The patient will be randomly assigned to receive the cautery incision on the left or right side. The same surgeon will make all of the skin incisions and perform the skin closures in order to provide as much standardization as possible. The closure will be standardized.<br>* Other names: bovie;|
| Active Comparator: Scalpel Incision<br>Scalpel to make skin incision | Procedure: Cautery vs Active Control Arm (Scalpel)<br>* Interventions: The cautery used will be the standard operating room monopolar cautery used at our institution. The cautery will be used on a cut setting of 20 with a blend setting of zero (pure cut). A standard protected needle tip cautery will be used. A #15 blade carbon steel scalpel blade will be used on ½ of the incision; a cautery device with the above-mentioned settings will be used on the other ½ of the wound. The patient will be randomly assigned to receive the cautery incision on the left or right side. The same surgeon will make all of the skin incisions and perform the skin closures in order to provide as much standardization as possible. The closure will be standardized.<br>* Other names: bovie;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is the Vancouver Scar Scale |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual scar scale done by both the subject and an independent observer |  | 2 week | 
| Visual scar scale done by both the subject and an independent observer |  | 3 months | 
| Visual scar scale done by both the subject and an independent observer |  | 6 months | 
| Visual scar scale done by both the subject and an independent observer |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scarring