Scalpel vs Diathermy in Making Abdominal Wall Incision During Repeat Cesarean Delivery
Phase: NA
Conditions: Complications; Cesarean Section
Sponsor: Texas Tech University Health Sciences Center

 
 
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RANDOMIZED CLINICAL TRIAL OF DIATHERMY VERSUS SCALPEL IN 
ABDOMINAL WALL INCISION   DURING   REPEAT CESAREAN   DELIVERY 
 
Principal Investigator: Martin Caliendo, M.D. 
Sub-Investigator:  Leela Sharath Pillarisetty, M.D, PGY3. 
Department of Obstetrics and Gynecology, Odessa, TX 
 
INTRODUCTION / BACKGROUND 
Cesarean delivery (CD) is the operative mode of the delivery, which includes 
laparotomy (skin incision) and hysterotomy (uterine incision) in order to facilitate the 
delivery of the newborn. In the modern obstetric practice in the United States one in 
three women who gave birth did so by CD. (1). Cesarean birth can be life-saving for the 
fetus, the mother, or both in certain cases. The rate of primary CD has increased and 
more women prefer elective repeat cesarean delivery (ERCD) (2).This  increased rate 
of cesarean deliveries is associated with the short- and long-term maternal 
complications (3) such as  RBC transfusion (2) . Among approaches used to reduce the 
rate of the postoperative complications are prophylactic administration of antibiotics (4) 
and improvement of surgical techniques (5). In particular, the improvement of surgical 
technique could contribute to more than two-fold decrease in post-operative morbidity 
(5).The application of techniques of the abdominal incision during CD is associated with 
hysterotomy approaches and subsequently maternal morbidity in specific patient 
populations (6). 
 
During surgical procedures, one of the widely used approaches to decrease blood loss, 
surgery time and thus post-operative complications is tissue dissection by 
electrosurgery, which is defined as the process of applying high-frequency electric 
current to the tissues to cut, coagulate, and desiccate (7). After the introduction of 
electrosurgery into the practice of surgery in 1926 by William T Bovie and Dr. Harvey W 
Cushing (8), it has since become a powerful  tool in different surgical subspecialties 
(9)(7).  
 
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Electrosurgical instruments are widely used for tissue dissections and to control 
bleeding, as an easy and safe surgical approach, but their use in making skin incisions 
is limited. The major purported disadvantages of electrosurgical skin incisions are fears 
of deep  burns; with resultant scaring (10),  slower wound healing , and increased 
postoperative pain . However, recent  meta-analyses showed decreased incision time, 
blood loss and post-operative pain with no significant difference in wound infection rates 
or scar (13)(14). 
With improved techniques of electrosurgery, several randomized trials - the gold 
standard of clinical research, were performed. A  randomized double blind study (15) 
performed in 369 patients, showed that diathermy  incision is superior compared to 
scalpel incision with  reduced incision time, less blood loss and reduced early 
postoperative pain. The same advantages have been reported using advanced 
diathermy technology by Lee et al(16).  The mechanism of  these positive effects of 
cutting electrosurgey  is that the skin  is  cut  with an electrode  delivering  pure  
sinusoidal  current,  which allows tissue cleavage by rapid cell vaporization without 
damage to surrounding areas; this may explain the absence of tissue charring  and the 
subsequent healing with minimal scarring (17). 
 
Taking together, the recently published advantages of diathermy in the skin incision 
could be extremely useful in preventing complications and decreasing maternal 
morbidity associated with CD.  However, there are no clinical trials comparing scalpel 
and diathermy in the population of pregnant patients undergoing CD. To perform such 
trials will have direct translational value. In situations of emergency cesarean sections, 
as an example, it will provide important information on which method will be fastest with 
the least amount of blood loss. 
 
OBJECTIVE 
The objective of this study is to compare scalpel vs. diathermy in abdominal wall 
incision, in pregnant patients undergoing repeat elective cesarean delivery. 
 
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HYPOTHESIS 
We hypothesize that the abdominal wall incisions made by diathermy compared to 
scalpel during repeat cesarean delivery will have less incision time, as well as less 
blood loss. Further we hypothesize that the use of diathermy, compared with scalpel will 
not increase post-operative pain.  
 
METHODS 
1) This is a randomized prospective study in women undergoing elective repeat 
cesarean delivery or repeat unplanned non-emergent cesarean delivery at 
Medical Center Hospital in Odessa Texas. 
2) After informed consent is obtained, women undergoing cesarean delivery will be 
randomized into two groups:  
Group One 
Will undergo diathermy to incise the entire abdominal wall, which includes skin, 
subcutaneous tissue, rectus muscle until the peritoneal cavity is visible.  
Group Two 
Scalpel will be used to achieve the same aims 
  
3)  Only patients undergoing elective repeat cesarean delivery will be enrolled, this 
will decrease the likelihood of introducing bias into the outcome measures, as 
well as it will make the population more uniform.  
4) A standardized abdominal wall incision will be made with either diathermy in cut 
mode or scalpel. Diathermy will be set in a cut mode with standard setting as per 
surgeon’s preference. All patients in the study will get standard skin incision in 
terms of length and depth which will be marked by a ruler. 
5)  Incision start and stop time will be recorded by a “timer”.  A digital wall clock in 
the OR will be used to establish time. The timer will instruct the surgeon to “cut”. 
The timer will record the time. Once the surgeon reaches the abdominal 
peritoneum, they will announce “stop”. The timers will record the time. The 
incision time will be the difference between the “cut” and “stop” times. These 
times will be recorded in units of seconds. 
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6) Along the incision depth the bleeding points will be mopped with sponge laps, no 
suction will be used and total blood loss will be calculated by weighing the laps.  
 
7) Blood loss will be recorded as follows: A “used” lap sponge will weighed. A 
“fresh” lap sponge will be weighed. These weights will be recorded. Blood loss 
will be calculated as the differences in these two weights. These weights will be 
recorded in grams. 
 
8) As per standard of care spinal or epidural anesthesia will be administered by 
certified registered nurse anesthetist (CRNA). Post-operative pain will be 
managed as follows: 1) 300 micrograms of Morphine sulfate will be injected 
through then spinal needle or epidural catheter at the beginning of the case. 2) 
30 milligrams of Toradol will be injected IM, in the left thigh, at the conclusion of 
the case. 3) 10 mg hydrocodone/325mg acetaminophen 1-2 tablets, per oral, 
every 4-6 hours, PRN pain. 
9) Post-operative pain will be measured by a Numeric Pain Rating Scale (see 
below) scored as 0= no pain, up to 10= worst possible pain. This score will be 
assessed daily by resident staff at 6:00 to 7:00 AM from post –op day 1 until 
hospital discharge. 
10) As per standard MCH protocol, within one hour preoperatively, Ancef 2-3gms will 
be administered IV. If the patient is Penicillin allergic, she will receive either 900 
milligrams of Clindamycin or 1gram of Vancomycin.  
 
OUTCOMES-  
Both groups will be assessed for  
Primary outcomes: 
  1. Incision time 
  2. Blood loss  
            
Secondary outcome: 
           1. Postoperative pain  
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SELECTION OF PATIENTS   
 
Inclusion Criteria -  
1. Multiparous pregnant women 18 – 45 years.   
2. Gestational ages 37 weeks to 41 weeks,  
3. Undergoing repeat elective or repeat unplanned non-emergent cesarean 
deliveries.  
 
Women with medical comorbidities like hypertension, diabetes complicating 
pregnancy, pregnant women with or without prenatal care, and multiple 
gestations will also be included.  
 
Exclusion Criteria –  
1. Informed consent can’t be obtained in a manner that allows for no impression 
of undue influence/pressure or sufficient time for patient to consider 
participation.  
2. Primary Cesarean deliveries – as these can bias the selection.  
3. Skin conditions such as infections, psoriasis, and eczema.  
 
RECRUITMENT PLAN 
Patients from University Women`s Health Centre (Texas Tech OBGYN clinic) and also 
from Medical Center Hospital, Odessa, Texas will be recruited. Potential participants will 
be identified by a member of the study team or clinic/hospital personnel caring for the 
patient. In the latter case, study personnel will be contacted to meet the patient after the 
patient has expressed an interest in learning more about participation.  All the 
participants will have the study procedures, risks, benefits and alternatives explained by 
a member of the study team.   
 
Once informed consent is obtained they will be randomized with 1:1 allocation by a 
computer generated randomization process. Since the annual rate of cesarean 
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deliveries in the above-mentioned centers ranges 150 to 175, we expect to enroll a total 
of 100 patients, and we will allocate 50 patients to each group. Assuming a significance 
level of 0.05 and a power of 80%, and observing that there is a single measurement and 
null attrition rate, we will be able to detect at least moderate effect sizes (d=0.50) when 
performing independent means comparisons. 
 
RISKS: 
Diathermy – 
A. Possibility of poor wound healing,  
B. There are concerns that large or excessive scars may form,   
C. Unanticipated burns on skin, subcutaneous tissues and other vital organs.  
 
Scalpel –  
A. Injury to the major blood vessels.  
B. Injury to the vital organs. 
C. Excessive bleeding 
 
From the review of recent literature there are some concerns raised regarding the use 
of diathermy for skin incisions (10, 11, 12). However, we believe that the use of cutting 
diathermy, as described in our protocol, does not increase patient risk within the study 
group.  First, there is a concern that diathermy, while making skin incisions, may 
increase the risk of wound complications, as well as delayed wound healing. However 
these studies differ from ours in a number of ways: A) Most studies claiming increase in 
risk examine midline abdominal incisions, and our study employs Pfannenstiel skin 
incision. B) In some studies it is unclear if pure cut mode was employed. The use of a 
blend mode will cause more lateral spread of current. This may increase the amount of 
tissue damage, thus promoting wound complications. Our study will employ diathermy 
only in pure cut mode in a standard setting as per surgeon’s preference.  A recent 
Cochrane review, which includes only randomized trials (the highest form of scientific 
inquiry), found no significant difference in wound complications between scalpel and 
diathermy (18). 
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Second, there has been a case report of a severe burn injury on patients back while 
utilizing diathermy during cesarean delivery (19). The purported mechanism for this 
burn was an interaction between diathermy and amniotic fluid (19). However in our 
study, cutting diathermy will be used only in incision of skin, subcutaneous fat and 
rectus fascia. This use precludes any interaction between diathermy and amniotic fluid. 
 
ADVERSE EVENTS REPORTING: 
Any event deemed as an Adverse Event that is possibly related or unexpected to the 
study will be assessed at each data gathering point and will be reported to the TTUHSC 
IRB as described in the IRB policies and procedure manual.  Monitoring of adverse 
events will start on the day of surgery. 
 
BENEFITS – There are no guarantees of any benefit to study participants. However, 
participants may have potential benefits of using electrosurgery which include reducing 
the amount of blood loss, dry and rapid separation of tissues. For surgeons, there is a 
reduced risk of accidental cut injuries. 
 
DATA ANALYSIS : 
Distributions of operative time, blood loss and post-operative pain will be tested for 
normal distribution. Student’s T test or the non-parametric equivalent will be used to 
compare these outcomes between the study and control group. Significance level will 
be set at 0.05. 
 
 
DATA MONITORING PLAN: 
All data for each participant will undergo quality assurance monitoring by personnel not 
listed as a member of the study team.  The purposes of this monitoring are to verify that: 
(a)  The rights and well-being of human subjects are protected. 
(b) The reported trial data are accurate, complete, and verifiable from source 
documents. 
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(c) The conduct of the trial is in compliance with the currently approved 
protocol/amendment(s), 
with 
GCP, 
and 
with 
the 
applicable 
regulatory 
requirement(s). 
 
RESULTS  
Expected results will be the finding of less operative time, blood loss, postoperative 
pain, in diathermy abdominal wall incisions compared to scalpel incisions, in pregnant 
women undergoing repeat cesarean deliveries. 
 
CONCLUSION  
To our knowledge, this study will be the first to compare the results of diathermy vs 
scalpel abdominal wall incisions in pregnant women undergoing cesarean deliveries.  
The study results can be used to help determine which method of incision is preferably 
used especially in case of emergency cesarean deliveries where time is a crucial factor.  
 
Numeric Pain Rating Scale: 
 
 
 
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