Benifits of Using Diathermy in Skin IncisionNCT04818710
Scalpel Versus Diathermy Skin Incision in Repeated CS
A study testing skin incision with a scalpel and skin incision with diathermy in people with Benifits of Using Diathermy in Skin Incision, run by National Research Centre, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Benifits of Using Diathermy in Skin Incision
- What is being tested?
- skin incision with a scalpel and skin incision with diathermy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 476 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Scalpel and Diathermy Skin Incision in Repeated Cesarean Section
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.
Read the 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
- incision time,
- incision blood loss,
- hemodynamic changes,
- postoperative pain,
- wound healing
- wound complications.
- Being tested
- skin incision with a scalpel, skin incision with diathermy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin incision with a scalpelProcedure or surgery
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 or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| skin incision with a scalpel | Placebo comparator | In the scalpel group, the incision was made by the traditional method, with proper homeostasis by applying pressure to skin blood vessels and ligating the subcutaneous bleeding. Receives: Procedure: skin incision with a scalpel |
| skin incision with diathermy | Active comparator | In the diathermy group, the incision made using a small flat blade pen electrode, set on cutting mode and delivering a 120 watt (maximum) sinusoidal current, electrosurgical cutting performed without pressure or mechanical displacement. Receives: Procedure: skin incision with diathermy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: 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.
Measured: during the first day after surgery
Secondary outcomes (2)
wound healing
healing by primary versus secondary intention
Measured: during the first week after surgery
wound complications
like seroma, hematoma, ecchymosis, dehiscence (separation of the subcutaneous tissues with skin), and infection
Measured: during the first week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 May 2019
- Primary completion31 Dec 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benifits of Using Diathermy in Skin IncisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 476 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Responsible party
- Principal investigator, Mazen Abdel Rasheed, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818710
- Sponsor's protocol ID
- diathermy skin incision
- Status last verified
- Mar 2021
- First submitted
- 20 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Scalpel and Diathermy Skin Incision in Repeated Cesarean Section
- ClinicalTrials.gov ID
- NCT04818710
- Acronym / sponsor ID
- diathermy skin incision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 476 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- incision time,
- incision blood loss,
- hemodynamic changes,
- postoperative pain,
- wound healing
- wound complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| skin incision with a scalpel | Placebo comparator | Procedure: skin incision with a scalpelIn the scalpel group, the incision was made by the traditional method, with proper homeostasis by applying pressure to skin blood vessels and ligating the subcutaneous bleeding. |
| skin incision with diathermy | Active comparator | Procedure: skin incision with diathermyIn the diathermy group, the incision made using a small flat blade pen electrode, set on cutting mode and delivering a 120 watt (maximum) sinusoidal current, electrosurgical cutting performed without pressure or mechanical displacement. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin incision with a scalpelA 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) | Procedure or surgery | skin incision with a scalpel |
| skin incision with diathermyA 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) | Procedure or surgery | skin incision with diathermy |
Primary outcome
incision time
Time frame: during surgical operation. the difference between starting skin incision till the rectus sheath was visualized
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".
incision blood loss
Time frame: during surgery
This was calculated by weighing the swabs pre and postoperatively (1mg = 1ml) after complete hemostasis was achieved.
postoperative pain
Time frame: during the first day after surgery
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.
2 secondary outcomes
wound healing
Time frame: during the first week after surgery
wound complications
Time frame: during the first week after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin incision with a scalpel and skin incision with diathermy in people with Benifits of Using Diathermy in Skin Incision, run by National Research Centre, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incision time (time frame: during surgical operation. the difference between starting skin incision till the rectus sheath was visualized). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.