Clinical trial NCT00803140: Cutaneous Scarring of Scalpel Versus Cautery
Official title: A Pilot Study Comparing Cutaneous Scarring When Scalpel Versus Cautery is Used to Make Skin Incisions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Scars
Keywords: scarring
Lead sponsor: Scott and White Hospital & Clinic
Sponsor class: OTHER
First posted: 2008-12-05
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria: Inclusion Criteria:

1. Patients undergoing primary, elective panniculectomy.
2. Patients must voluntarily be enrolled in the study after informed consent.
3. Patients must be in relative good health and have adequate nutrition.
4. Patients of all races and genders will be included.
5. Patients must agree to refrain from the use of topical scar products during the study period.

Exclusion Criteria:

1. Under the age of 18 years old
2. Patients with previous history of hypertrophic or keloid scarring
3. Patients presenting for scar revision
4. Patients presenting for a non-elective surgery
5. Patients with chronic immunosuppression or wound healing problems
6. 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,
7. Use of any tobacco products

Primary outcomes:
measure: The primary outcome measure is the Vancouver Scar Scale
timeFrame: 12 months
Secondary outcomes:
measure: Visual scar scale done by both the subject and an independent observer
timeFrame: 2 week
measure: Visual scar scale done by both the subject and an independent observer
timeFrame: 3 months
measure: Visual scar scale done by both the subject and an independent observer
timeFrame: 6 months
measure: Visual scar scale done by both the subject and an independent observer
timeFrame: 12 months
Other outcomes:
Locations:
city: Temple
country: United States
facility: Scott and White Hospital and Clinic
state: Texas
Study officials:
affiliation: Scott and White Hospital & Clinic
name: Raman C Mahabir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen DQ, Potokar T, Price P. A review of current objective and subjective scar assessment tools. J Wound Care. 2008 Mar;17(3):101-2, 104-6. doi: 10.12968/jowc.2008.17.3.28666.
citation: van Zuijlen PP, Angeles AP, Kreis RW, Bos KE, Middelkoop E. Scar assessment tools: implications for current research. Plast Reconstr Surg. 2002 Mar;109(3):1108-22. doi: 10.1097/00006534-200203000-00052.
citation: Papay FA, Stein J, Luciano M, Zins JE. The microdissection cautery needle versus the cold scalpel in bicoronal incisions. J Craniofac Surg. 1998 Jul;9(4):344-7. doi: 10.1097/00001665-199807000-00010.
citation: Sheikh B. Safety and efficacy of electrocautery scalpel utilization for skin opening in neurosurgery. Br J Neurosurg. 2004 Jun;18(3):268-72. doi: 10.1080/02688690410001732715.
citation: Molgat YM, Pollack SV, Hurwitz JJ, Bunas SJ, Manning T, McCormack KM, Pinnell SR. Comparative study of wound healing in porcine skin with CO2 laser and other surgical modalities: preliminary findings. Int J Dermatol. 1995 Jan;34(1):42-7. doi: 10.1111/j.1365-4362.1995.tb04379.x.
citation: Middleton WG, Tees DA, Ostrowski M. Comparative gross and histological effects of the CO2 laser, Nd-YAG laser, scalpel, Shaw scalpel and cutting cautery on skin in rats. J Otolaryngol. 1993 Jun;22(3):167-70.