Scalpel Versus Diathermy Skin Incision in Repeated CS

National Research Centre, Egypt476 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

476

Conditions

Benifits of Using Diathermy in Skin Incision

Interventions

skin incision with a scalpelPROCEDURE

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)

skin incision with diathermyPROCEDURE

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)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

National Research Centre

Cairo, Egypt

Outcomes

Primary Outcomes

incision time

We 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".

Time frame: during surgical operation. the difference between starting skin incision till the rectus sheath was visualized

incision blood loss

This was calculated by weighing the swabs pre and postoperatively (1mg = 1ml) after complete hemostasis was achieved.

Time frame: during surgery

postoperative pain

We 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.

Time frame: during the first day after surgery

Secondary Outcomes

wound healing

healing by primary versus secondary intention

Time frame: during the first week after surgery

wound complications

like seroma, hematoma, ecchymosis, dehiscence (separation of the subcutaneous tissues with skin), and infection

Time frame: during the first week after surgery

Data from ClinicalTrials.gov

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