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CompletedNCT06352853Updated Apr 9, 2024

Scalpel Versus Diathermy in Transverse Abdominal Skin Incision During Cesarean Section

An interventional study of Skin incision in Cesarean Section by Diathermy and Skin incision in Cesarean Section by Scalpel in Skin Wound, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-09.

Sponsored by Cairo University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Apr 2022, registered Apr 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

This study aims to compare between using of diathermy versus scalpel in making skin incision during cesarean section to judge the variations in incisional time, incisional blood loss, postoperative pain, wound healing and wound complications.

Read the detailed description

Surgical scalpels are traditionally used for skin incisions during a Caesarean delivery; the great evolutions in electrosurgical devices bring an alternative method for skin incision by the usage of cutting diathermy.

The current comparative study was conducted in Kasr Al-Ainy hospital obstetric theaters between January 2022 and June 2022. Consents were obtained from all participants. 120 participants were included in this study, divided into 2 groups 60 in each group;Diathermy group and scalpel group respectively .

  • Randomization achieved using computer generated randomization sequences. Allocation was in 1:1 ratio

In both groups:

  1. Pre-operative: patients received cefoperazone 1gm intravenous. In case of penicillin allergy, they received clindamycin intravenous.
  2. A Pfannenstiel skin incision was made taken down through the subcutaneous tissue, rectus sheath and dissected from rectus muscle until peritoneum was visualized,

    • In scalpel group; an incision made by traditional method, with proper homeostasis by application of pressure to skin blood vessels and by ligating the subcutaneous bleeding as well as using of diathermy on coagulation mode. Then, the investigators used the scalpel to reach peritoneum.
    • In diathermy group; incision made using a small flat blade pen electrode, set on cutting mode and delivering a 120-wat (maximum) sinusoidal current, electrosurgical cutting performed without pressure or mechanical displacement. Then, the investigators used the scalpel to reach peritoneum.
    • The study compared incisional time by using digital clock, time established as follows: when skin incision made, the surgeon called out "start the clock". After opening the rectus sheath, the surgeon called out" stop the clock". Incision time is the difference between "start" and "stop".

    Also incision blood loss was calculated by weighing the swabs pre and postoperatively (1mg = 1ml). In incisional site no suction was used.

    •Also hemodynamic changes were compared between both groups that include: blood pressure (systolic blood pressure, diastolic blood pressure and mean arterial blood pressure), pulse, oxygen saturation and electrocardiogram (ECG) changes.

  3. Intra-operative: patient received Diclofenac sodium 50-100 mg intramuscular and postoperatively, they received paracetamol vial /6 hours in both groups.

Closure of the skin in all cesarean sections was done by proline 2.0 for assessment of wound healing and complications.

Postoperatively, the postoperative pain was compared for 24 hours by visual analogue scale (VAS) score, It is 11 points numeric scale ranges from "0" representing one pain extreme (e.g.: no pain) to "10" representing the other pain extreme (e.g.: "pain as bad as you can imagine" or "worst pain imaginable") this will be recorded at 2,4, 6,8, 10,12, 24 hours postoperatively.

Lastly, wound healing was compared in both groups and complications like seroma, hematoma, ecchymosis, dehiscence and infection. The presence or absence of infection was assessed by Southampton grading system as following:

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 and in this case wound culture was performed.

02

Conditions studied

  • Skin Wound

Keywords

  • Diathermy-Scalpel-skin incision-Cesarean section
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Elective cesarean section.
  • Women with body mass index less than 30.
  • Transverse skin incision.

Exclusion criteria

Exclusion Criteria:

  • Women with medical disorder that can affect wound healing as diabetes, hypertension, chronic anemia and with chronic skin conditions as psoriasis and eczema.
  • Women with Autoimmune disorders.
  • Cardiac patients on pacemakers and patients on anticoagulants.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Group 1: Scalpel Group

    A skin incision is made by traditional method, with proper homeostasis by application of pressure to skin blood vessels and by ligating the subcutaneous bleeding as well as using of diathermy on coagulation mode. Then,the scalpel was used to reach peritoneum.

    Other: Skin incision in Cesarean Section by Scalpel

  • Active comparator
    Group 2: Diathermy Group

    A skin incision is made using a small flat blade pen electrode, set on cutting mode and delivering a 120-wat (maximum) sinusoidal current, electrosurgical cutting performed without pressure or mechanical displacement. Then, we used the scalpel to reach peritoneum.

    Other: Skin incision in Cesarean Section by Diathermy

Interventions

  • OtherSkin incision in Cesarean Section by Diathermy

    Skin incision by diathermy

  • OtherSkin incision in Cesarean Section by Scalpel

    Skin incision by scalpel

06

What researchers measure

Primary outcomes

  1. Skin incision time in scalpel versus diathermy group

    The incision time was estimated by using digital clock, time established as follows: when skin incision made, the surgeon called out "start the clock". After opening the rectus sheath, the surgeon called out" stop the clock". Incision time is the difference between "start" and "stop".

    Time frame: 5 months

  2. Estimation of incision blood loss in both groups

    incision blood loss volume was measured by weighing the swabs pre and postoperatively (1mg = 1ml).

    Time frame: 5 months

Secondary outcomes

  1. Postoperative pain in both groups

    Evaluation of post operative pain for 24 hours by visual analogue scale

    Time frame: 5 months

  2. Postoperative wound healing in both groups

    Postoperative wound complications like seroma, hematoma, ecchymosis, dehiscence (separation of the subcutaneous tissues with skin) and infection. The presence or absence of infection was assessed by Southampton grading system as following: 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 and in this case wound culture was performed.

    Time frame: 5 months

07

Study locations

1 site
  • Shaimaa El Shemy
    Giza, Cairo Governorate 11562, Egypt
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: 10 years

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2022 to primary completion in Sep 2022, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2024
First posted
Apr 8, 2024
StartActual
Apr 1, 2022
Primary completionActual
Sep 1, 2022
CompletionActual
Oct 1, 2022
Last update
Apr 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06352853
Lead sponsor
Cairo University
Responsible party
Shaimaa Mostafa Mohammed Refaay El shemy (Lecturer at Obstetrics and Gynecology department, Cairo University) — Principal investigator
First posted
Apr 8, 2024
Start date
Apr 1, 2022
Primary completion
Sep 1, 2022
Completion
Oct 1, 2022
Last update
Apr 9, 2024

Study contacts

Shaimaa El Shemy, MD
principal investigator · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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