Cold Knife Versus Monopolar Electrosurgery in Abdominal Incisions

Electrosurgery Versus Scalpel Clinical Trial

Official title:

Cold Knife Versus Monopolar Electrosurgery for Abdominal Incisions ( Clinical Trial )

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04236401
• Other study ID #: Electrosurgery
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2020
• Est. completion date: May 2021

Study information

• Verified date: February 2020
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the aim of work is to compare the early postoperative and late term wound complication rates between the scalpel and electrosurgery in patients with benign gynecological conditions undergoing abdominal incisions.

Description:

• Study Hypothesis: - Using electrosurgery decrease incision blood loss, decrease postoperative pain, decrease wound time incision, decrease analgesia requirements, doesn't increase wound sepsis.

Type of study: - Randomized controlled trial study (parallel group study with 1:1 randomization) will be conducted at gynecology department of Alzhraa University Hospital of faculty of Medicine for girls - Cairo within 1 year according to sample size. A computer randomization will be generated and held with one of the experimenter, and (n) of black and red card will be used for allocation concealment.

Participants at morning of the operation will be given information about the study aims and written consent will be taken.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: May 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• All patients scheduled for elective gynecological abdominal surgeries for benign diseases

• willing to participate in the study.

• The participants will receive 2 gm cephalosporines preoperative per hospital policy.

Exclusion Criteria:

• History of receiving antibiotics during the preceding 7 days,

• chronic medical illness like diabetes, asthma or tuberculosis,

• patients have anemia,

• surgically scarred tissues,

• Immuno-compromised patients,

• pregnant patients,

• patients with pacemaker device,

• patients on anticoagulants therapy

Related Conditions & MeSH terms

• Electrosurgery Versus Scalpel
• Surgical Wound

Intervention

Procedure:
• electrosurgery will be used for abdominal incision
electrosurgery will be used to open anterior abdominal wall and electrosurgery will be used for heamostasis also
• scalpel will be used for abdominal incision
scalpel will be used for abdominal wall incision and thread will be used for haemostsis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound incision time	measure time needed to open anterior abdominal wall in minutes by stopwatch	at the beginning of each surgery
Primary	Wound infection	rate of infection in wound after surgery as inflammation, seroma, heamatoma, gapping, sepsis or fever	after surgery till primary healing of the wound, an average of 15 days after operation
Secondary	Postoperative pain (pain score 2-4 hr postoperative).	using Visual Analogue Scale; the higher scores mean worse outcome	during first 4 hours after surgery
Secondary	Amount of Analgesia needed during 1st 12 hr after surgery .	dose of analgesia needed	first 12 hours after surgery
Secondary	Wound-related blood loss	by weighing towel before and after abdominal wall incision / grams	after opening anterior abdominal wall during each surgery
Secondary	number of participants with bad scar formation or keloid	scar condition evaluation after complete healing of the wound. early healing after 15 days of the surgery and after complete healing after 45 days of the surgery	through study completion, an average of 1.25 year