Clinical Trial: Cutaneous Scarring of Scalpel Versus Cautery
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Pilot Study Comparing Cutaneous Scarring When Scalpel Versus Cautery is Used to Make Skin Incisions
Brief 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.
Detailed Summary:
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.
Same as current
Current Secondary Outcome:
- Visual scar scale done by both the subject and an independent observer [ Time Frame: 2 week ]
- Visual scar scale done by both the subject and an independent observer [ Time Frame: 3 months ]
- Visual scar scale done by both the subject and an independent observer [ Time Frame: 6 months ]
- Visual scar scale done by both the subject and an independent observer [ Time Frame: 12 months ]
Original Secondary Outcome: Visual scar scale done by both the subject and an independent observer [ Time Frame: 2 week, 3, 6 and 12 months ]
Information By: Scott and White Hospital & Clinic
Dates:
Date Received: December 3, 2008
Date Started: November 2008
Date Completion:
Last Updated: May 27, 2015
Last Verified: May 2015
