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Steel Scalpel versus Electrocautery Blade: Comparison of. Cosmetic and Patient Satisfaction Outcomes of Different. Incision Methods. Jason K.M. Chau, BSc, ...
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Steel Scalpel versus Electrocautery Blade: Comparison of Cosmetic and Patient Satisfaction Outcomes of Different Incision Methods Jason K.M. Chau, BSc, MD, Peter Dzigielewski, MD, Alex Mlynarek, MD, FRCSC, David W. Cote, MD, MPH, Heather Allen, RN, Jejfery R. Harris, MD, FRCSC, and Hadi R. Seikaly, MD, FRCSC ABSTRACT Objective: To determine which method of skin incision has superior cosmetic and patient satisfaction outcomes. Methods: Consenting patients undergoing bilateral neck dissection who met the inclusion criteria were prospectively enrolled. Each side of the neck was randomly assigned into one of the following two groups: scalpel incision and electrocautery incision. Cosmetic and patient satisfaction outcomes were collected prospectively with patients and outcome assessors blinded to group assignment. Validated self-report questionnaires and objective scar measures were used. Results: Nineteen patients met the criteria for inclusion. Analysis revealed no significant differences between groups in terms of cosmetic or satisfaction outcomes. Use of the steel scalpel was found to result in significantly greater incision-related blood loss compared with use of the electrocautery blade. Conclusion: Steel scalpel or electrocautery may be used to incise the skin of patients undergoing bilateral neck dissection with no difference in cosmetic or patient satisfaction outcome. The steel scalpel yields greater incision-related blood loss compared with the electrocautery blade. SOMMAIRE Objectif: L'étude avait pour but de déterminer quelle technique d'incision de la peau était supérieure à l'autre sur les plans de l'esthétique et de la satisfaction des patients. Méthode: Des patients volontaires, qui devaient subir une dissection bilatérale du cou et qui répondaient aux critères de sélection ont été triés de façon prospective. La répartition dans les groupes d'incision: au scalpel ou à l'électrocautère, a été déterminée au hasard, et ce, pour chaque côté du cou. Il y a eu collecte prospective de données sur les résultats esthétiques et la satisfaction des patients, fournies par les sujets eux-mêmes et par des évaluateurs de résultats, tenus dans l'ignorance de l'appartenance au groupe. Nous nous sommes appuyés sur des questionnaires validés d'autoévaluation et sur des mesures objectives de cicatrice. Résultats: Dix-neuf patients répondant aux critères de sélection ont participé à l'étude. L'analyse n'a pas révélé de différence importante entre les deux groupes en ce qui concerne les résultats esthétiques et la satisfaction des patients. Cependant, les pertes de sang liées à l'incision étaient significativement plus grandes avec le scalpel d'acier qu'avec la lame de l'électrocautère. Conclusions: L'incision de la peau en vue d'une dissection bilatérale du cou peut se faire aussi bien au scalpel d'acier qu'à l'électrocautère, et ce, sans différence sur les plans de l'esthétique et de la satisfaction des patients. Cependant, les incisions faites au moyen du scalpel d'acier entraînent des pertes de sang plus importantes que celles faites au moyen de la lame de l'électrocautère. Key words: clinical trial, cosmetic outcomes, electrocautery, patient satisfaction, scalpel, skin incision

Jason K.M. Chau, Peter Dzigielewski, Alex Mlynarek, David W. Cote, Heather Allen, Jeffery R. Harris, and Hadi R. Seikaly: Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Alberta, Edmonton, Alberta. Presented at the 62nd Annual Canadian Society of Otolaryngology-Head and Neck Surgery meeting, Jasper, AB, June 1, 2008. Address reprint requests to: Jason K.M. Chau, BSc, MD, 5355 Terwillegar Blvd, Edmonton, AB T6R 3H9.

DOI 10.2310/7070.2009.080080 © 2009 The Canadian Society of Otolaryngology-Head & Neck Surgery

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he two most widely used and studied methods of performing an incision in the head and neck are the steel scalpel and electrocautery blade. The main advantages of the steel scalpel are its ease of use, accuracy, and minimal adjacent tissue damage effect.' It can, however, lead to collateral injury of surgical assistants as it is passed to the scrub nurse and may potentially cause considerable incisional blood loss. Electrosurgery devices provide enhanced hemostasis by sealing off blood vessels before they are cut. They use heat energy to denature protein.

DECKEI^ Journal of Otolaryngology-Head & Neck Surgery, Vol 38, No 4 (August), 2009: pp 427-433

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which leads to vascular tamponade and eventual hemostasis. Despite being beneficial in terms of blood loss, there is a potential distinct disadvantage of using heat energy in surgical wounds. Thermal dissipation into the surrounding tissue may lead to collateral damage to vital structures, increased postoperative pain caused by sensory nerve injury, delayed wound healing, and poor cosmetic outcome.^"^ The steel scalpel and electrocautery blade have been compared in terms of postoperative pain, incision speed, blood loss, wound healing, and complication rate in human and animal trials,''^'^ but no comparative studies between the two have been performed with regard to cervical skin incision and the resultant cosmetic and patient satisfaction outcomes. Cervicofacial disfigurement and scarring have been identified as a major contributor to head and neck cancer patients' overall quality of life.'^"^^ Facial disfigurement may be a result of the cancer process itself or a result of the surgical treatments employed. It has been recognized not only as the most stressful aspect of head and neck but as an enormous threat to self-esteem as In fact, facial disfigurement has been linked to the high rates of depression and anxiety known to exist in head and neck cancer patients.^^"^'' The purpose of this study was to compare the traditional scalpel blade incision method with that of the electrocautery blade in a prospective, controlled, randomized, double-blind fashion. The primary objective was to determine which method is superior in terms of cosmetic healing and patient satisfaction, as measured by both subjective and objective scar scales. Secondary outcomes compared include blood loss, speed of incision, collateral injury to surgical assistants, and postoperative complication rate.

Methods Research Questions The research questions are seen below: 1. Does electrocautery blade skin incision result in superior postoperative cosmetic healing and patient satisfaction results when compared with the traditional steel scalpel blade? 2. Does electrocautery blade skin incision afford superior results in terms of incision-related blood loss, incision speed, collateral injury, and postoperative complication rates when compared with the traditional steel scalpel?

Hypotheses The research hypotheses are seen below: 1. The electrocautery blade provides postoperative cosmetic healing and patient satisfaction results comparable to those of the steel scalpel. 2. The electrocautery blade provides operative blood loss, incision speed, collateral injury, and postoperative complication rates comparable to those of the steel scalpel.

Setting The study was conducted in a tertiary-level care academic referral centre. Ethics Approval The Health Research Ethics Board of the Capital Health region granted full approval of this trial. Case report forms, data collection forms, patient information letters, and the consent form were reviewed and fully approved. Patient Recruitment and Enrolment All recruitment was conducted and consent was obtained by staff or resident physicians affiliated with the Division of Otolaryngology-Head and Neck Surgery of the University of Alberta. Consecutive patients who presented for consultation at the tertiary care head and neck oncology clinic from July to September 2007 were approached for recruitment in the study if the inclusion criteria were satisfied. Enrolment occurred following obtainment of informed consent. Inclusion criteria were as follows: 1. Age ^ 1 8 years 2. Patients undergoing surgery for malignant disease of the head and neck that requires bilateral neck apron incisions 3. Ability to comprehend and complete a written or verbal questionnaire Exclusion criteria were as follows: 1. Age < 18 years 2. Inability to comprehend and complete a written or verbal questionnaire

Treatment Groups, Randomization, and Concealment Each side of each patient's neck was randomized into the scalpel (control) or the electrocautery blade (intervention)

Chau et al. Comparison of Steel Scalpel versus Electrocautery Blade

group at the time of enrolment. Each patient therefore acted as his or her own control. Random assignment into each group was achieved through computer-based random number generation software. Block randomization was used to ensure that equal numbers of neck incisions were allocated to each group. Croup assignment was concealed via opaque white envelopes and was revealed after the induction of anesthesia. Characteristics of the Control and Intervention in Question Control group A standard number 15 scalpel blade was used as the control in this trial. This blade is commonly used not only by head and neck surgeons but also by many surgical subspecialties at the University of Alberta. Intervention group A Bovie electrocautery blade incision at a standardized setting of 20 watts, "blend one" setting, was the intervention in question in this trial. This technology, as with the scalpel blade, is commonly used not only by head and neck surgeons but also by many surgical subspecialties at the University of Alberta.

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appearance. A 10-point visual analogue scale was used to assess patients' overall satisfaction. The Vancouver Scar Scale (VSS) was employed as an objective measure of cosmetic results.'"' The VSS is a validated objective measure of scars in burn patients but has been validated in other patient groups, including patients with linear scars.*' The above measurements were taken at 6 months postoperatively. Secondary Outcomes Secondary outcomes included incision-related blood loss, incision speed, collateral injury, and postoperative complication rate: 1. Incisional blood loss was measured by comparing operative sponge weight before and after use. A standard operating room (OR) scale was used to measure the sponges to the nearest tenth of a gram. Standard error was estimated at ± 0.2 g. 2. Incision speed was measured with a standard OR suite stopwatch clock. Time was recorded to the nearest second. The estimated margin of error was ± 3 seconds. 3. Collateral injury was measured by simple counts. 4. The postoperative complication rate was measured prospectively and recorded on standardized case report forms.

Objective Outcome Assessors and Blinding Naive outcome assessors participated in this study. They were blind to the given neck's group assignment in that they were not involved with the operative procedure or any of the postoperative care. Naive assessors possessed background medical knowledge but were naive to the exact details of the specific procedures. Naive assessors included fourth-year medical students and first-year core surgery residents. Outcomes, Outcome Measures, and FoUow-Up Primary Outcome Subjective patient-graded cosmetic scar appearance as measured by the validated Patient Observer Scar Assessment Scale (POSAS) was the primary outcome used to compare the two groups.^^ This is a patient self-rated continuous scale ranging from 0 to 10 that has been validated in head and neck cancer patients.^' This instrument also provides an objective component in which assessors may give their own rating of scar healing and

Follow Up At the University of Alberta, head and neck cancer patients are seen regularly in follow-up. For the purposes of this trial, subjective and objective assessments were made at the 6-month postoperative time frame. Surgical Study Protocol The following surgical protocol was used for all enrolled patients: 1. Apron-style incisions were demarcated on cervical skin first with a sterile marking pen. 2. A local anesthetic injection was not used so as to minimize possible confounding vasoconstrictive effects. 3. Randomization envelopes were then opened, and the appropriate group allocation was recorded on the standardized case report form. 4. The start time of the incision was chosen as when the epidermis was first breached. The OR stopwatch was started at this time.

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5. Surgical sponges were weighed preoperatively and postoperatively in their sterile packaging. Sponge packets were assigned to each side of the neck preoperatively and were kept separate from each other before, during, and after their use. The same OR scale was used for all measurements on all patients. The estimated error, as reported by the company, was ± 0.2 g. 6. The deep margin of the incision in all patients was that of the subplatysmal plane. 7. The stop time of the incision was defined as when hemostasis was achieved. 8. Closure of the neck incisions was in a dual-layer fashion. The platysmal layer was closed with 3-0 Vicryl suture and the skin with a running 4-0 Monocryl suture. 9. All operative data points were recorded on a standardized case report form and kept secure in a locked OR cabinet until trial completion.

Statistics The primary outcome measure of patient-rated cosmesis (continuous variable) as measured by the POSAS was used a priori to calculate the necessary sample size. A minimal clinically important difference (MCID) of 2.08 on this scale and a standard deviation of 1.98 were imputed based on a previous report in a similar patient population.^^ Assuming a standard normal distribution of two groups with equal variances and an intraindividual correlation of 0.6 (and the above-stated MCID and standard deviation), we calculated that 16 incisions were required in each group. Significance level, power, and confidence levels were set at 0.05, 80%, and 95%, respectively. Intention-to-treat analysis was applied to the data. Categorical variables (count variables) were compared using the Fisher exact test. Continuous variables were analyzed using paired t-tests. Multivariate regression analysis was employed to assess for any significant intervariable relationships. Kappa was employed as a means of assessing agreement between independent assessors.

the general epidemiologic gender distribution of head and neck cancer. The mean Fitzpatrick skin class of the sample was 2. Three patients (15.8%) had had previous chemoradiation treatments. Nine patients (47%) had had postoperative adjuvant chemoradiation treatment (Table 1). All patients had bilateral neck dissections via apron-style neck incisions. Comparative analysis of subjective patient-rated scar appearance scores yielded no significant differences between the steel scalpel and electrocautery blade. No significant differences were found in the patient component of the POSAS or patients' overall satisfaction scores, as given in Table 2. Similarly, no significant differences in objective assessments were found between scalpel and cautery groups (Table 3). Objective component scores (of POSAS), VSS scores, and overall assessment scores were not significantly different between the treatment and control groups. Analysis of secondary outcomes revealed a significant difference in blood loss between the scalpel and cautery groups. The scalpel group had a mean blood loss weight of 17.16 g (± 8.11 g) versus 5.72 g (± 4.40 g) in the electrocautery group. This difference of 11.4 g was found to be statistically significant (p < .0001). No significant differences were found in speed of incision, collateral injury rate, or postoperative complication rate (Table 4).

Discussion The impact of surgical scars on the quality of life of head and neck cancer patients can be considerable. Cervicofacial scars can be a substantial source of stress for patients and may significantly impair a patient's self esteem.'^*"^^ In time, the disfigurement may contribute to the development of a mood or anxiety disorder.^^"''' Certainly, any means to minimize the surgical scars and optimize cosmesis should be employed for these patients.

Table 1. Patient Demographics Patient Parameter

Results Nineteen patients were prospectively enrolled, giving a total of 38 incisioris available for evaluation. All 19 patients completed the full 6-month follow-up. There were no losses to foUow-up and no missing data points. The mean age of the sample was 62.9 years (SD = 11.4 years). Males comprised 67% of the sample, fitting with

Sample size Total number of incisions Mean age, yr (SD) Male gender distribution Fitzpatrick class (mean) Chemoradiation history preoperatively Postoperative chemoradiation

Value 19 38 62.9 (± 11.4) 67% 2 3 (15.8%) 9 (47%)

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Table 2. Primary Outcome Data: Subjective Scores Scale

Steel Scalpel

Electrocautery

p Value

24.2 3.8

21.6 3.0

.518 .361

Steel Scalpel

Electrocautery

p Value

17.0 5.7 4.2

18.3 5.8 4.5

.732 .903 .738

POSAS, subjective total score (/60) Overall satisfaction score (/lO) POSAS = Patient Observer Scar Assessment Scale.

Table 3. Primary Outcome Data: Objective Scores < Scale

POSAS, objective total score (/50) VSS total score (/13) Overall assessment score (/lO)

POSAS = Patient Observer Scar Assessment Scale; VSS = Vancouver Scar Scale.

Table 4. Secondary Outcome Data Variable Incisional blood loss, g (SD) Incision speed, s (SD) Collateral injury Postoperative complication

Steel Scalpel

Electrocautery

Difference

p Value

17.16 (± 8.11) 239.06 (± 82.99)

5.72 (± 4.40) 210.33 (± 68.62)

11.44 28.72

< .0001

0

0 0

1 (5%)

Comparative studies between various surgical incision methods have been performed in both human and animal models. Liboon and colleagues compared mucosal incisions made by scalpel, CO2 laser, electrocautery, and constant-voltage electrocautery in a swine model based on the outcomes of histologie healing, performance, and ease of use.' They found the scalpel to have the fastest rate of incision and the least resultant histologie tissue damage. They also reported the scalpel to have the greatest associated bleeding but did not give a unit of quantification. Carew and colleagues employed a rat model to compare mucosal incisions between the scalpel, cautery, CO2 laser, and KTP laser.^ In terms of the main outcome measure of histologie healing, the scalpel blade was found to be superior to cautery, but no significant difference was found in the tensile strength of the scalpel or cautery wound. Sinha and Gallagher compared wound healing between the steel scalpel, ultrasonic scalpel, CO2 laser, and mono- and bipolar electrocautery in a guinea pig oral mucosa model' Outcomes measured were pain, histologie wound strength, hemostasis, and wound healing. The scalpel was best in terms of wound healing and histologie wound strength. Monopolar cautery and the CO2 laser were best in terms of pain level (measured via the proxy of weight changes), and the ultrasonic scalpel was best in terms of hemostasis.

0 1

.08

.807 .788

Human studies comparing scalpel and electrocautery incisions have predominantly been reported in the general surgery literature. Kearns and colleagues employed a randomized clinical study design to compare diathermy and scalpel incisions in patients undergoing elective midline laparotomy.'° Outcomes of incision time, wound size, blood loss, postoperative pain, and complication rate were compared. They reported electrocautery to have superior results in terms of incision time, blood loss, and postoperative pain when compared with the steel scalpel. No significant differences were noted in wound size or postoperative complication rate. In a multicentre study. Franchi and colleagues compared the scalpel blade with electrocautery in patients undergoing midline laparotomy incisions for uterine malignancies." With a sample size of 964 patients, they found scalpel blade incision (versus electrocautery) to be an independent risk factor for major postoperative wound infection along with the independent factors of increased body mass index (BMI) and advanced age. Odds ratios found for scalpel incision, increased BMI, and advanced age were 7.14, 8.8, and 4.14, respectively. Lastly, Chrysos and colleagues prospectively compared diathermy and scalpel incisions in tension-free hernioplasty patients.'^ The only significant difference found was in the levels of postoperative pain, as measured by analgesic use. Diathermy had significantly less associated

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postoperative wound pain when compared with the scalpel. No significant differences were found in blood loss, dehiscence rates, infection rates, or the number of days until staples were removed. The presented study has compared the cosmetic healing outcomes of the steel scalpel and electrocautery blade in head and neck cancer patients in a prospective, randomized, double-blind fashion. In our sample, no significant differences were found in subjective or objective ratings of cosmetic scar appearance at the 6-month postoperative time frame. Furthermore, no significant differences were found in overall patient satisfaction levels between the two incision methods. We thus propose that either of these two incision methods may be used to incise the skin of the head and neck as they yield similar cosmetic outcomes. Further comparative analysis revealed no significant differences in incision speed, collateral surgical assistant injury, or postoperative complication rate. Either method of incising skin may thus be chosen based on these outcomes. A significant difference in incisional blood loss was found between the scalpel and the electrocautery blade. Steel scalpel incision was found, on average, to result in 11.4 g (p < .0001) greater blood loss when compared with the electrocautery blade. This difference may perhaps not be clinically significant in larger head and neck ablative or reconstructive procedures but may, in fact, be important in smaller head and neck surgery cases. We suggest that this difference be considered and taken into account in more routine general head and neck surgery cases.

Conclusion When considering cosmetic appearance and patient satisfaction outcomes, the steel scalpel and electrocautery blade yield comparable results. The electrocautery blade gives incisional hemostatic outcomes superior to those of the scalpel blade. The scalpel and cautery blade do not differ significantly in terms of incision speed, collateral injury rate, or postoperative complication rate.

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