Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06352853
Study type Interventional
Source Cairo University
Contact
Status Completed
Phase N/A
Start date April 1, 2022
Completion date October 1, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT03947450 - Autologous Volar Fibroblast Injection Into the Stump Site of Amputees Phase 2
Completed NCT01437852 - StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns Phase 1
Active, not recruiting NCT03649308 - Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting N/A
Recruiting NCT05984628 - Umbilical Cord Stem Cells for Skin Grafts in Donor Site Wounds N/A
Completed NCT05112679 - Limb Health and Socket Pressure in Response to Powered Ankle Protheses N/A
Completed NCT03795116 - Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention Phase 2
Recruiting NCT04557761 - Comparison of microMend® Devices to Sutures in Closing Lacerations in Children N/A
Active, not recruiting NCT03394612 - Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Full-Thickness Skin Defects in Adults and Children Phase 2
Withdrawn NCT05643755 - Preoperative Image-based Education Effect on Postoperative Satisfaction of Patients Undergoing First-time Dermatologic Surgery N/A
Completed NCT03754218 - Amnion Wound Covering for Enhanced Wound Healing Early Phase 1
Active, not recruiting NCT05517902 - StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects Phase 3
Terminated NCT03005054 - StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects Phase 2
Completed NCT03960164 - Dermal Regeneration Photosynthetic Matrix Early Phase 1