Cesarean Section WoundNCT03120806
Interrupted Versus Continuous Subcuticular Skin Suturing in Elective Cesarean Section.
A study testing Interrupted subcuticular skin closure and continuous subcuticular skin closure in people with Cesarean Section Wound, run by Cairo University at 1 site in Egypt.
Trial summary
Non-diabetic pregnant women who undergo elective CS will be randomized into two groups: group I included women who has their skin closed with subcuticular interrupted mattress suture using non-absorbable polypropylene, and group II included women who has their skin closed with subcuticular continous suture using the… Read more about this study
- Who is it for?
- Ages 19 to 39 years, women only
- Conditions the study is for
- Cesarean Section Wound
- What is being tested?
- Interrupted subcuticular skin closure and continuous subcuticular skin closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Apr 2017to 20 Dec 2017
- 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 19 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 years or older
- Overall good health
- Elective Cesarean section ASA class 1 or 2
Who cannot join
- Allergy to synthetic suture materials
- Diabetes whether gestational or pregestational
- use of steroid or immunosuppresive medication within last 6 month of procedure
- Skin sepsis or systemic fever
- BMI > 35
- History of keloid or hypertrophic scar formation or dermatologic conditions known to impair wound healing ASA class 3 or 4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Interrupted and Continuous Subcuticular Skin Suturing in Women Undergoing Elective Cesarean Section. A Randomized Controlled Trial
Non-diabetic pregnant women who undergo elective CS will be randomized into two groups: group I included women who has their skin closed with subcuticular interrupted mattress suture using non-absorbable polypropylene, and group II included women who has their skin closed with subcuticular continous suture using the same suture material
Read the detailed description
Non-diabetic pregnant women who undergo elective CS will be randomized into two groups: group I included women who had their skin closed with subcuticular interrupted mattress suture using non-absorbable polypropylene, and group II included women who had their skin closed with subcuticular continous suture using the same suture material.
- Conditions
- Cesarean Section Wound
- Being tested
- Interrupted subcuticular skin closure, continuous subcuticular skin closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interrupted subcuticular skin closureProcedure or surgery
skin is closed with interrupted mattress subcuticular sutures using non-absorbable polypropylene after elective cesarean section
continuous subcuticular skin closureProcedure or surgery
skin is closed with continuous subcuticular sutures using non-absorbable polypropylene after elective cesarean section
| Study group | Role | What they receive |
|---|---|---|
| continous subcuticular | Active comparator | skin closed with continous subcuticular mattress suture using non-absorbable polypropylene Receives: Procedure: continuous subcuticular skin closure |
| Interrupted subcuticular | Active comparator | skin closed with interrupted subcuticular mattress suture using non-absorbable polypropylene Receives: Procedure: Interrupted subcuticular skin closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound infection
occurrence of signs of wound infection
Measured: 10 days after surgery
Secondary outcomes (5)
scar dehiscence
occurrence of scar dehiscence or incisional hernia
Measured: 10 days after surgery
wound seroma
occurrence of seroma of wound
Measured: 10 days after surgery
the need for reclosure
actual gapping of wound
Measured: 10 days after surgery
postoperative pain
through visual analogue score The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
Measured: 12 hours after surgery
wound hematoma
occurrence of subcutanous hematoma
Measured: 10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start16 Apr 2017
- Primary completion1 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120806
- Sponsor's protocol ID
- 167
- Status last verified
- Dec 2021
- First submitted
- 16 Apr 2017
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Interrupted and Continuous Subcuticular Skin Suturing in Women Undergoing Elective Cesarean Section. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03120806
- Acronym / sponsor ID
- 167
- Conditions
- Cesarean Section Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Apr 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 19 Apr 2017 (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.
Non-diabetic pregnant women who undergo elective CS will be randomized into two groups: group I included women who has their skin closed with subcuticular interrupted mattress suture using non-absorbable polypropylene, and group II included women who has their skin closed with subcuticular continous suture using the same suture material
Detailed description
Non-diabetic pregnant women who undergo elective CS will be randomized into two groups: group I included women who had their skin closed with subcuticular interrupted mattress suture using non-absorbable polypropylene, and group II included women who had their skin closed with subcuticular continous suture using the same suture material.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continous subcuticular | Active comparator | Procedure: continuous subcuticular skin closureskin closed with continous subcuticular mattress suture using non-absorbable polypropylene |
| Interrupted subcuticular | Active comparator | Procedure: Interrupted subcuticular skin closureskin closed with interrupted subcuticular mattress suture using non-absorbable polypropylene |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 years or older
- Overall good health
- Elective Cesarean section ASA class 1 or 2
Key exclusion criteria (6 listed)
- Allergy to synthetic suture materials
- Diabetes whether gestational or pregestational
- use of steroid or immunosuppresive medication within last 6 month of procedure
- Skin sepsis or systemic fever
- BMI > 35
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 |
|---|---|---|
| Interrupted subcuticular skin closureskin is closed with interrupted mattress subcuticular sutures using non-absorbable polypropylene after elective cesarean section | Procedure or surgery | Interrupted subcuticular |
| continuous subcuticular skin closureskin is closed with continuous subcuticular sutures using non-absorbable polypropylene after elective cesarean section | Procedure or surgery | continous subcuticular |
Primary outcome
wound infection
Time frame: 10 days after surgery
occurrence of signs of wound infection
5 secondary outcomes
scar dehiscence
Time frame: 10 days after surgery
wound seroma
Time frame: 10 days after surgery
the need for reclosure
Time frame: 10 days after surgery
postoperative pain
Time frame: 12 hours after surgery
wound hematoma
Time frame: 10 days 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 23 Dec 2021.
- Individual participant dataSharing planned: Yes
Related trials for Cesarean Section Wound
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Narrative Nursing for Cesarean Mothers' Anxiety and Breastfeeding Confidence
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Effect of Betadine Vaginal Cleansing Before Cesarean Section to Reduce Postoperative Infectious Morbidity
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Not yet recruiting
Effect of Bioptron Light Therapy on Wound Healing After Caesarean Section
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Steri-Strip Application Versus Standard Wound Closure for Cesarean Section Incisions
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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.
Ahmed Maged, MD principal investigator
Kasr Alainy medical school
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interrupted subcuticular skin closure and continuous subcuticular skin closure in people with Cesarean Section 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 6 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 23 Dec 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. 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?
wound infection (time frame: 10 days after surgery). 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 23 Dec 2021; AzTrials last refreshed its copy on 28 Oct 2026.