Cutaneous Scarring of Scalpel Versus Cautery

Scars Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

• Scars

• NCT number: NCT00803140
• Study type: Interventional
• Source: Scott and White Hospital & Clinic
• Status: Terminated
• Phase: N/A
• Start date: November 2008
• Completion date: April 2013