Background: Surgical incisions are routinely made with scalpel or diathermy where diathermy is then further used for hemostasis and dissection of deeper tissues. Skin incision with diathermy is believed to cause burns, delayed healing and scarring. The modern electro surgical units that are capable of delivering pure sinusoidal current producing cleavage in tissue planes without creating damage to the surrounding tissues, thus reducing damage inflicted to tissues leading to minimal scar formation is an answer to these roadblocks.[1] The advantages are rapid hemostasis, faster dissection, and a reduced overall operative blood loss.[2] In an era of explosive aesthetic agents, electro-surgical instruments were used only selectively in surgery. However, the use of diathermy still has reservations in making skin incisions. The reluctance lies in the fear that electro surgical instruments create increased amounts of necrotic tissue within the wound which may increase the chances of wound infection leading to delayed wound healing and excessive scarring. Materials and Methods: The prospective randomized controlled study was carried out for a duration of one year from January 2024 to December 2024 in the department of General Surgery at Indira Gandhi Institute of Medical Sciences, Patna. The patients admitted for elective abdominal surgery were included in the study fulfilling the inclusion and exclusion criteria. A written informed consent was obtained from all the patients coupled with counselling about the merits and demerits of each method. Simple random sampling was used for allocation of the patients into Group ‘Scalpel’ and Group ‘Diathermy’. The patients along with the assessor was blinded. The operating surgeon was not blinded. Results: A total of 498 patients were included in the study those meeting the inclusion criteria. A total of 76 patients were excluded. After randomization, 211 patients were allocated to ‘Scalpel’ group and 211 patients were allocated to ‘Diathermy’ group. A total of 35 patients, 18 patients in ‘Scalpel’ group and 17 in ‘Diathermy’ group, were lost to follow-up. ‘Scalpel’ consisted of a total of 193 patients with 101 males and 92 females, mean age= 48.65 years with standard deviation of 16.85 years and range of 18 to 83 years. ‘Diathermy’ consisted of a total of 194 patients with 99 males and 95 females, mean age= 45.85 years with standard deviation of 15.15 years and range of 18 to 76 years. Conclusion: Skin incisions via did not exhibit a significant propensity to develop postoperative wound infections, contrary to prior hypotheses. Furthermore, the nociceptive response associated with these incisions was notably diminished during the immediate postoperative phase. Although electrosurgical incisions demonstrated a marked superiority over scalpel incisions with respect to reduced incision duration and minimized blood loss, it is imperative to consider the potential complications inherent to both methodologies in juxtaposition with their advantages prior to making an informed decision.
Surgical incisions are routinely made with scalpel or diathermy where diathermy is then further used for hemostasis and dissection of deeper tissues. Skin incision with diathermy is believed to cause burns, delayed healing and scarring. The modern electro surgical units that are capable of delivering pure sinusoidal current producing cleavage in tissue planes without creating damage to the surrounding tissues, thus reducing damage inflicted to tissues leading to minimal scar formation is an answer to these roadblocks.[1] The advantages are rapid hemostasis, faster dissection, and a reduced overall operative blood loss.[2] In an era of explosive aesthetic agents, electro-surgical instruments were used only selectively in surgery. However, the use of diathermy still has reservations in making skin incisions. The reluctance lies in the fear that electro surgical instruments create increased amounts of necrotic tissue within the wound which may increase the chances of wound infection leading to delayed wound healing and excessive scarring.
However, post introduction of oscillator units which produce pure sinusoidal current, there has been an increasing trend in the use of diathermy for making skin incisions. In the recent years, many studies have been conducted to compare these methods of making skin incision, with regards to operative duration amounts of blood loss, pain following surgery and effects on wound healing [3,4]. This randomized controlled study was carried out to compare the incision time, blood loss during incision, post operative pain, quality of wound healing and wound complications using diathermy versus scalpel for skin incision.
The prospective randomized controlled study was carried out for a duration of one year from January 2024 to December 2024 in the department of General Surgery at Indira Gandhi Institute of Medical Sciences, Patna. The patients admitted for elective abdominal surgery were included in the study fulfilling the inclusion and exclusion criteria. A written informed consent was obtained from all the patients coupled with counselling about the merits and demerits of each method. Simple random sampling was used for allocation of the patients into Group ‘Scalpel’ and Group ‘Diathermy’. The patients along with the assessor was blinded. The operating surgeon was not blinded.
Inclusion criteria- all patients admitted in the surgery department for elective abdominal surgical procedures. Exclusion criteria- 1) Age <18 years. 2) Any malignant disease. 3) Chronic medical illness like diabetes, asthma, tuberculosis. 4) Gross infection of operative site. 5) non consenting patients. 6) those lost to follow-up. Complete medical history and physical examination was performed for all patients along with the required laboratory and radiological work-up before scheduling the procedure. All the patients were operated under either spinal or general anesthesia. The abdominal skin hair was clipped just before the surgery and was prepared with 10 % povidone iodine solution. A prophylactic dose of one gram of intravenous ceftriaxone was administered one hour prior to the skin incision. The skin and subcutaneous tissue were incised via ‘Scalpel’ group or a monopolar diathermy pen set on cutting mode ‘Diathermy’ group. The wound closure in both groups was carried out with Vicryl for the subcutaneous tissue and Nylon for the skin. A 10 ml solution of 0.2% bupivacaine was infiltrated in the wound and 75 mg diclofenac was administered 12 hourly intramuscularly in both groups for the pain control. The incision time and blood loss during incision was documented in each group. The blood loss during incision was explicitly measured by the number of gauzes soaked and its weight till hemostasis was achieved. The incision time was measured from start of skin incision up till aponeurosis dissection and achieving of hemostasis. The patients were clinically evaluated for postoperative pain on day 0, day1 and day 2 using visual analogue scale (VAS). Wound healing was assessed on the 7th postoperative day using the ‘Southampton Grading system: G0: normal wound healing, G1: normal healing with mild bruising or erythema, G2: erythema plus other signs of inflammation, G3: clear or serosanguinous discharge, and G4: purulent discharge. The Manchester scar scale was used for assessing the quality of the scar which includes color, matte or shiny, contour, distortion and texture. The patients were followed up in 2nd, 4th, 6th week and 6 months after the discharge and any readmission after discharge from the hospital was evaluated to detect the occurrence of late wound complications.
Statistical analysis was performed by using IBM SSPS software version 30.0.0 using chi-square test, Fischer exact test and Student’s t tests. A value of p <0.05 was considered significant.
A total of 498 patients were included in the study those meeting the inclusion criteria. A total of 76 patients were excluded. After randomization, 211 patients were allocated to ‘Scalpel’ group and 211 patients were allocated to ‘Diathermy’ group. A total of 35 patients, 18 patients in ‘Scalpel’ group and 17 in ‘Diathermy’ group, were lost to follow-up. ‘Scalpel’ consisted of a total of 193 patients with 101 males and 92 females, mean age= 48.65 years with standard deviation of 16.85 years and range of 18 to 83 years. ‘Diathermy’ consisted of a total of 194 patients with 99 males and 95 females, mean age= 45.85 years with standard deviation of 15.15 years and range of 18 to 76 years.
The incision time and incisional blood loss were significant amongst the two groups. The mean time to incise the skin and subcutaneous tissue till aponeurosis while maintaining hemostasis was significantly higher in in the ‘Scalpel’ was higher than the ‘Diathermy’ (p<0.001). The mean incision time observed in ‘Scalpel’ Group was 62.96 + 31.87 seconds; range: 6.87 - 128.09 seconds and the mean incision time noted in ‘Diathermy’ group was 5.34 -100.76 + 12.34 seconds; range: 5.34 -100.76 seconds. (Table 1)
The blood loss during incision in group was also significantly higher in ‘Scalpel’ Group than the ‘Diathermy’ Group; p value: <0.00001 (Table 1). The mean blood loss during incision in ‘Scalpel’ Group was 4.0 + 0.56 ml and in ‘Diathermy’ Group was 1.93 + 0.88 ml. The comparative analysis of pain score according to the visual analogue scale and analgesia requirement amongst the two group revealed no significant difference on the postoperative Day 2 but was significantly lower in diathermy group on the day of the surgery (Day 0) and Day 1; p value on Day 0=0.00001, Day 1 = 0.00786 and on Day 2= 0.454 (Table 2). The grades of wound healing across the different classes of surgery amongst the two groups were significant only in grade 3 and grade 4 wound healing; p value= 0.454. Overall, n=7 ,3.6% and n=8, 4.1% showed hematoma formation in ‘Scalpel’ and ‘Diathermy’ group respectively. The rate of wound dehiscence and hematoma in the two groups in the various type of surgery was also not observed to be statistically significant (p value =0.886458 and 0.953149) (Table 3).
On evaluating the outcome of scars in both the groups based on ‘Manchester scar scale’ at 1.5 months and 6 months following discharge, there was no statistical difference with p value of 0.100 and 0.457 respectively (Table 4). The quality was scars were alike in the ‘diathermy’ group at 1.5 as well as at 6 months.
There was marginally higher number of non-healing wound or wound complications in the ‘diathermy’ cohort than the ‘Scalpel’ cohort (3.09% vs 2.6%) (Table 5), although the readmission rates were similar in both the groups (n=3, 1.55%). However, the assessment of these parameters did not reveal a statistically significant p value (Table 5).
Table 1: Comparative analysis of incision time and blood loss during incision.
|
|
N |
Range
|
Mean (in seconds) |
Standard deviation |
CI
|
P value
|
Incision time in seconds |
Scalpel
|
193 |
6.87 - 128.09 seconds |
62.96 |
31.87 |
7.1441 - 16.7959. |
0.001 |
|
Diathermy
|
194 |
5.34 -100.76 seconds |
50.99 |
12.34 |
|
|
Blood loss during incision (in ml) |
Scalpel |
193 |
3.1-5.0 |
4.0 |
0.56 |
1.9225 -2.2175.
|
0.00001 |
|
Diathermy
|
194 |
0.5-3.5 |
1.93 |
0.88 |
|
|
Table 2: Comparative analysis of postoperative pain.
|
|
N
|
Mean
|
Standard deviation |
CI
|
P value
|
Pain score (VAS), Day 0 |
Scalpel
|
193 |
8 |
1.42 |
0.344 to 0.856. |
0.00001 |
|
Diathermy
|
194 |
8.6 |
1.12 |
|
|
Pain score (VAS), Day 1 |
Scalpel
|
193 |
7.06 |
2.96 |
-0.5158 to 0.5958
|
0.00786 |
|
Diathermy
|
194 |
6 |
2.59 |
|
|
Pain score (VAS), Day 2 |
Scalpel
|
193 |
7.34 |
1.87 |
-0.2281 TO 0.5481. |
0.454 |
|
Diathermy
|
194 |
7.18 |
2.01 |
|
|
Table 3: Comparative analysis of wound complications.
|
|
Clean (Scalpel group, n=82); (Diathermy group, n=86) |
Clean-contaminated (Scalpel group, n=63); (Diathermy group, N=59) |
Contaminated (Scalpel group, n=39); (Diathermy group, N=44)
|
Dirty (Scalpel group, N= 9); (Diathermy group, N=5) |
P value |
Scalpel N=193
|
G1-G2
|
60 |
48 |
19 |
3 |
0.264057. |
Diathermy N=194 |
G1-G2
|
79 |
39 |
28 |
3 |
|
|
|
|
|
|
|
|
Scalpel N=193
|
G3-G4 |
22 |
15 |
20 |
6 |
0.043136 |
Diathermy N=194 |
G3-G4 |
7 |
20 |
16 |
2 |
|
|
|
|
|
|
|
|
Scalpel N=193
|
Wound dehiscence
|
2 |
5 |
23 |
6 |
0.886458. |
Diathermy N=194 |
Wound dehiscence
|
1 |
5 |
15 |
3 |
|
|
|
|
|
|
|
|
Scalpel N=193
|
Hematoma
|
4 |
6 |
1 |
0 |
0.953149 |
Diathermy N=194 |
Hematoma
|
2 |
5 |
0 |
1 |
|
Table 4: The evaluation of scar according to the ‘Manchester scar scale’.
Mean ‘Manchester scar score’ at |
Scalpel N=193
|
Diathermy N=194 |
p value |
1.5 months |
13.4 + 1.03 |
11.4 + 2.33 |
0.100 |
6 months |
8.82 + 1.03 |
8 + 0.95 |
0. 457 |
Table 5: Evaluation of late wound complications amongst the groups.
|
Non healing wound observed after 6 months (n, %) |
Readmissions (n, %)
|
P value |
Scalpel N=193
|
5, 2.6% |
3 ,1.55% |
>0.05 |
Diathermy N=194 |
6, 3.09% |
3, 1.55% |
|
Since its realization to achieve better hemostasis and dissection, diathermy is extensively used in surgical interventions. Newer electrosurgical instruments have streamlined the management of complex surgical procedures. However, there is continuing reluctance for skin incision by some surgeons due to the belief of raised devitalization of the skin and subcutaneous tissues consequenting to delayed healing, poor cosmesis and increased wound infection. Chrysos E et.al. has put forth the observation that local tissue heating while using diathermy increased subcutaneous oxygen tension, amplifying the resistance of the tissues to surgical site infections [5]. Electrosurgical incision involves molecular breakdown of tissue along the electrode's trajectory, rather than a sharp cut. Consequently, surgeons employing this technique must possess adequate training and a thorough familiarity with electrosurgical procedures, including an understanding of the impact of the wound's local environment on the healing process [6].
We noted in our study that there was significantly lower time taken to incise the skin and subcutaneous tissue with better hemostasis allowing better surgical field visualization. Although larger subcutaneous veins not controlled by diathermy was ligated which augmented the incision time and blood loss in certain cases in the diathermy cohort. Kearns et al. in their study [7] also reported significantly lower incision time during laparotomy via diathermy than scalpel incisions (mean 6.1±0.4vs. 7.5±0.5s/cm2; p=0.04); also, significantly less blood loss in the diathermy group compared with the scalpel group (0.8±0.1vs. 1.7±0.3ml/cm2; p=0.002). Sheikh's comparison of skin incisions in 177 neurosurgical cases revealed that utilizing a micro-needle electrocautery scalpel significantly reduced both the time required for skin opening and the amount of blood loss compared to a traditional steel scalpel, with a low incidence of wound dehiscence (one case) [8]. Miller et al. [9] found significantly less operative blood loss in cautery patients than in scalpel patients in their study of 49 mastectomies. The diathermy uses for skin incisions in all general surgical procedures within the trial by Shamim et al. [10] was observed to correlate with a decreased incision duration and diminished incisional blood loss, largely attributable to the intrinsic hemostatic mechanism of diathermy.
The mean pain score assessed by the visual analogue scale on the postoperative day 0 and day 1 was lower in ‘diathermy’ cohort nonetheless mean pain score observed on postoperative day 2 were similar with no significant difference. Though, Kearns observed that patients in the diathermy group reported significantly lower postoperative pain scores during the initial 48 hours following surgery (p<0.05). The lower postoperative visual analogue pain scores in the first 48 hours are likely due to the cell vaporization from pure sinusoidal current application, which causes immediate tissue and nerve necrosis without substantial damage to nearby structures, thus extensively damaging or minimally affecting cutaneous nerves in the surgical area [5,11]. Pearlman et al., however noted than the postoperative pain and wound healing was similar in the diathermy and scalpel skin incision [12].
To compare the wound complications, we had classified the wound as clean, clean-contaminated, contaminated and dirty in both the groups. Majority of the cases belonged clean and clean contaminated class across the groups with better wound healing (G1-G2) in the clean and clean-contaminated class. Poor grades of healing (G3-G4) in minority of the cases in ‘scalpel’ and ‘diathermy’ groups across clean (n=22, 26.82%) and clean contaminated class (n=15, 17.44%) of surgery (Table 3). Conversely, majority of the cases in the contaminated (‘Scalpel’ group, n=20, 51.3% and ‘Diathermy’, n=16 ,36.36 %) and dirty class (‘Scalpel’ group, n=6, 66.67% and ‘Diathermy’, n=2, 40%) had poor grades (G3-G4) of wound healing.’ Significantly lower rates of poor wound healing were noted in the ‘Diathermy’ group contrarily better grades of wound healing not affected by the use of scalpel or diathermy. Majority cases of hematoma formation was seen in clean surgery in the ‘Scalpel’ group whereas ‘Diathermy’ group had most cases of it in the clean- contaminated wound. Even so, Rate of hematoma formation was similar and not significant in this study. Most wound dehisced in the contaminated and the dirty class across the groups. ‘Scalpel’ group and ‘Diathermy’ group saw 36 (18.6%) and 24 (12.4%) cases of wound dehiscence overall and the analysis did not reveal a significant p value (Table 3). The prevalence of postoperative wound infections as documented in separate investigations exhibits a lack of uniformity. Stolz et.al [13] reported scalpel incision or diathermy thoracotomy incision did not influence early or late wound complication whereas another study by Franchi et. al. [14] found higher incidence of severe wound complications in the scalpel group than the electrocautery group (8/531 vs. 1/433; p<0.05) similar to our study. Notwithstanding the heterogeneity in methodologies across prior investigations, the metanalysis by Ahmad et.al. validated their conclusions, suggesting an equivalent incidence of wound infection irrespective of the skin incision technique employed [15].
On follow-up at 1.5 months and 6 months post discharge, analogous scar formation was seen in the ‘Diathermy’ group with ‘Manchester scar score’ ranging from 9 to 16 and 7 to 15 at 1.5 and 6-months post discharge. On the other hand, ‘Diathermy’ group had slightly higher score and poor scar formation with scores ranging from 10 to 17 and 8 to 17 at 1.5 months and 6 months post discharge. These data portrayed a similar wound healing in both cohorts akin to the previous trials. Limited number of prior published trials have considered the aesthetic outcomes associated with skin incisions created via electrosurgery or scalpel exploiting VSS or POSAS measurements of cosmetic outcome in 19 patients by Chau et.al [16], patient-reported preference and surgeon evaluation of photographs of the scar in 31 patients by Stupart et.al [17] and the inter-rater agreement between patients’ and surgeon’s scar evaluation in a total of 66 patients by Aird et.al [18].
One of the significant limitations of diathermy is the generation of smoke or plume resulting from the combusting tissues. The dissemination of this plume through the air poses a considerable risk to the medical personnels and other individuals present in the operating theater. This plume is comprised of chemical and cellular detritus and, in addition to its carcinogenic properties, has the potential to induce bacterial, viral, and chemical infections. In light of these numerous hazards, concerted efforts have been made to effectively evacuate the plume from the surgical environment. The application of diathermy without implementing these precautionary measures is deemed unsafe and is therefore inadvisable [19-23]. Furthermore, alcohol-based skin preparations have been implicated in accidental diathermy burns, necessitating the adoption of stricter precautionary measures during their use [24]. In operating rooms, healthcare workers frequently acquire infections through accidental needlestick or sharps injuries, with surgical scalpels being the second most implicated instrument [25].
Skin incisions via did not exhibit a significant propensity to develop postoperative wound infections, contrary to prior hypotheses. Furthermore, the nociceptive response associated with these incisions was notably diminished during the immediate postoperative phase. Although electrosurgical incisions demonstrated a marked superiority over scalpel incisions with respect to reduced incision duration and minimized blood loss, it is imperative to consider the potential complications inherent to both methodologies in juxtaposition with their advantages prior to making an informed decision. Lastly, the surgeon's individual preference and level of expertise may take precedence in the selection against diathermy incisions; however, the gradual evolution observed in recent years should be sustained.