Skin WoundNCT06352853
Scalpel Versus Diathermy in Transverse Abdominal Skin Incision During Cesarean Section
A study testing Skin incision in Cesarean Section by Diathermy and Skin incision in Cesarean Section by Scalpel in people with Skin Wound, run by Cairo University at 1 site in Egypt.
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. 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
- Skin Wound
- What is being tested?
- Skin incision in Cesarean Section by Diathermy and Skin incision in Cesarean Section by Scalpel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 1 Oct 2022
- 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
- Elective cesarean section.
- Women with body mass index less than 30.
- Transverse skin incision.
Who cannot join
- Women with medical disorder that can affect wound healing as diabetes, hypertension, chronic anemia and with chronic skin conditions as psoriasis and eczema.
- Women with Autoimmune disorders.
- Cardiac patients on pacemakers and patients on anticoagulants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between the Use of Scalpel Versus Diathermy in Opening the Transverse Abdominal Skin Incision During Cesarean Section
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.
Read the detailed 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:
- Pre-operative: patients received cefoperazone 1gm intravenous. In case of penicillin allergy, they received clindamycin intravenous.
- 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.
- 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.
- Conditions
- Skin Wound
- Being tested
- Skin incision in Cesarean Section by Diathermy, Skin incision in Cesarean Section by Scalpel
- Keywords
- Diathermy-Scalpel-skin incision-Cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin incision in Cesarean Section by DiathermyOther
Skin incision by diathermy
Skin incision in Cesarean Section by ScalpelOther
Skin incision by scalpel
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Scalpel Group | Active comparator | A skin incision is 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 scalpel was used to reach peritoneum. Receives: Other: Skin incision in Cesarean Section by Scalpel |
| Group 2: Diathermy Group | Active comparator | A skin incision is 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, we used the scalpel to reach peritoneum. Receives: Other: Skin incision in Cesarean Section by Diathermy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin incision time in scalpel versus diathermy group
The incision time was estimated 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".
Measured: 5 months
Estimation of incision blood loss in both groups
incision blood loss volume was measured by weighing the swabs pre and postoperatively (1mg = 1ml).
Measured: 5 months
Secondary outcomes (2)
Postoperative pain in both groups
Evaluation of post operative pain for 24 hours by visual analogue scale
Measured: 5 months
Postoperative wound healing in both groups
Postoperative wound complications like seroma, hematoma, ecchymosis, dehiscence (separation of the subcutaneous tissues with skin) 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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Apr 2022
- Primary completion1 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin WoundStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mostafa Mohammed Refaay El shemy, Cairo University
- Investigators
- Shaimaa El Shemy, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352853
- Sponsor's protocol ID
- Diathermy and skin incision cs
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 9 Apr 2024
- 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 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between the Use of Scalpel Versus Diathermy in Opening the Transverse Abdominal Skin Incision During Cesarean Section
- ClinicalTrials.gov ID
- NCT06352853
- Acronym / sponsor ID
- Diathermy and skin incision cs
- Conditions
- Skin Wound
- Keywords
- Diathermy-Scalpel-skin incision-Cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 8 Apr 2024 (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 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.
Detailed 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:
- Pre-operative: patients received cefoperazone 1gm intravenous. In case of penicillin allergy, they received clindamycin intravenous.
- 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.
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Scalpel Group | Active comparator | Other: Skin incision in Cesarean Section by ScalpelA skin incision is 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 scalpel was used to reach peritoneum. |
| Group 2: Diathermy Group | Active comparator | Other: Skin incision in Cesarean Section by DiathermyA skin incision is 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, we used the scalpel to reach peritoneum. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Elective cesarean section.
- Women with body mass index less than 30.
- Transverse skin incision.
Key exclusion criteria (3 listed)
- Women with medical disorder that can affect wound healing as diabetes, hypertension, chronic anemia and with chronic skin conditions as psoriasis and eczema.
- Women with Autoimmune disorders.
- Cardiac patients on pacemakers and patients on anticoagulants.
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 in Cesarean Section by DiathermySkin incision by diathermy | Other | Group 2: Diathermy Group |
| Skin incision in Cesarean Section by ScalpelSkin incision by scalpel | Other | Group 1: Scalpel Group |
Primary outcome
Skin incision time in scalpel versus diathermy group
Time frame: 5 months
The incision time was estimated 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".
Estimation of incision blood loss in both groups
Time frame: 5 months
incision blood loss volume was measured by weighing the swabs pre and postoperatively (1mg = 1ml).
2 secondary outcomes
Postoperative pain in both groups
Time frame: 5 months
Postoperative wound healing in both groups
Time frame: 5 months
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 9 Apr 2024.
- Individual participant dataSharing planned: Yes
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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.
Shaimaa El Shemy, MD principal investigator
Cairo University
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 in Cesarean Section by Diathermy and Skin incision in Cesarean Section by Scalpel in people with Skin Wound, run by Cairo University 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 3 inclusion and 3 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 9 Apr 2024. 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. 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?
Skin incision time in scalpel versus diathermy group (time frame: 5 months). The study lists 2 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 9 Apr 2024.