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Scalpel Versus Diathermy Skin Incision in Repeated CS

Comparative Study Between Scalpel and Diathermy Skin Incision in Repeated Cesarean Section

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04818710
Enrollment
476
Registered
2021-03-26
Start date
2019-05-01
Completion date
2021-01-31
Last updated
2021-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benifits of Using Diathermy in Skin Incision

Brief summary

This study was performed to compare both methods of skin incisions to determine differences in postoperative pain, hemodynamic changes, incisional time, blood loss during incision, wound healing, and wound complication.

Detailed description

Our study aims to compare the use of diathermy versus scalpel in making skin incision during cesarean section to judge the variations in 1. incision time, 2. incision blood loss, 3. hemodynamic changes, 4. postoperative pain, 5. wound healing 6. wound complications.

Interventions

PROCEDUREskin incision with a scalpel

A Pfannenstiel skin incision was done through the subcutaneous tissue, rectus sheath and dissected from rectus muscle until peritoneum was visualized. group 1 (skin incision with a scalpel)

PROCEDUREskin incision with diathermy

A Pfannenstiel skin incision was done through the subcutaneous tissue, rectus sheath and dissected from rectus muscle until peritoneum was visualized. group 2 (skin incision with diathermy)

Sponsors

Kasr El Aini Hospital
CollaboratorOTHER
National Research Centre, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* women with a history of only one previous cesarean section * age between 18 and 40 years * gestational age of 38 to 41 weeks * body mass index less than 30.

Exclusion criteria

* any medical disorder that can affect wound healing as diabetes, chronic anemia, chronic skin conditions, history of allergy, or history of an infected surgical wound. * Women who conducted primary or emergency cesarean deliveries * cardiac patients on pacemakers * patients on anticoagulants * women refusing to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
incision timeduring surgical operation. the difference between starting skin incision till the rectus sheath was visualizedWe compared incisional time by using a digital clock. The incisional time was established as follows: when skin incision was made, the surgeon called out start the clock. Once the rectus sheath was visualized, the surgeon calls out stop the clock. The incision time was the difference between start and stop.
incision blood lossduring surgeryThis was calculated by weighing the swabs pre and postoperatively (1mg = 1ml) after complete hemostasis was achieved.
postoperative painduring the first day after surgeryWe compared those patients clinically for postoperative pain for 24 hours by visual analog scale (VAS) score, a psychometric response scale, and it is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. 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 score was recorded for each participant at 2,4,6,8,10,12,24 hours postoperatively.

Secondary

MeasureTime frameDescription
wound healingduring the first week after surgeryhealing by primary versus secondary intention
wound complicationsduring the first week after surgerylike seroma, hematoma, ecchymosis, dehiscence (separation of the subcutaneous tissues with skin), and infection

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026