Cesarean SectionNCT03354078
Effect of Subcutaneous Tissue Closure on Wound Complications
A study testing interrupted sutures and continous sutures in people with Cesarean Section, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Only a small number of research studies evaluated the impact of various subcutaneous tissue and skin closure methods at cesarean section. In a meta-analysis a major decline in incision site rupture was revealed when suturing the subcutaneous tissue in women with a subcutaneous depth >2 cm. 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
- Cesarean Section
- What is being tested?
- interrupted sutures and continous sutures
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jun 2017to 23 Nov 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patients included in this research BMI ≥ 30, First cesarean section performed, no medical disorders with pregnancy e.g DM, HTN. All patients were subjected to full history taking, examination.
- depth of subcutaneous tissue estimated by a special device used (sterilized operative ruler). number of sutures estimation
Who cannot join
- The following patients were excluded BMI <30, Previous CS, DM with pregnancy, HTN with pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Subcutaneous Tissue Closure Technique in Cesarean Section on Reducing Postoperative Wound Complications
Only a small number of research studies evaluated the impact of various subcutaneous tissue and skin closure methods at cesarean section. In a meta-analysis a major decline in incision site rupture was revealed when suturing the subcutaneous tissue in women with a subcutaneous depth >2 cm.
Read the detailed description
Postoperative wound complications are one of the great issues in cesarean section (CS) with an incidence ranging from 3% to 30%.1 Obesity, operative time, diabetes, age of the patient, anemia, associated infection (e.g chorioamnionitis), the use of internal monitoring, delayed labor with many vaginal examinations and reduced nutrition are recognized risk factors for wound infections.
Evaluating the various techniques for closure of the subcutaneous layer.
- Conditions
- Cesarean Section
- Being tested
- interrupted sutures, continous sutures
- Keywords
- Cesarean section, Wound infection, Gapping
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interrupted suturesProcedure or surgery
The way of closing subcutaneous tissue either by interrupted
continous suturesProcedure or surgery
The way of closure of subcutanous tissue is by continous sutures
| Study group | Role | What they receive |
|---|---|---|
| interrupted sutures group | Active comparator | This group in which closure of the subcutaneous layer is closed by interrupted sutures Receives: Procedure: interrupted sutures; Procedure: continous sutures |
| Continous sutures group | Active comparator | subcutanous tissue layer is closed by continous sutures in this group Receives: Procedure: interrupted sutures; Procedure: continous sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants who passed without postoperative complications
Describes how many participant willnot complain from wound seroma , wound erythema and wound infection
Measured: one month post cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start18 Jun 2017
- Primary completion1 Nov 2017
- Study completion23 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alalfy, M.s.c, Study chair, Algazeerah hospital -Location (Giza -Egypt )
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354078
- Sponsor's protocol ID
- Cesarean section / sutures
- Status last verified
- Apr 2022
- First submitted
- 19 Nov 2017
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alalfy M, Elgazzar A, Fares T, Nagy O, Ellithy A, Lasheen Y, Kamel A, Soliman M, Hassan A, Samy A, Taher AM, Ogila AI, Saad H, Salah H, Ramadan M, Nabil M, Hatem DL, Fikry M. Effect of subcutaneous tissue closure technique in cesarean section on postoperative wound complications in obese Egyptian women. J Matern Fetal Neonatal Med. 2019 Aug;32(15):2452-2459. doi: 10.1080/14767058.2018.1438399. Epub 2018 Feb 20.
PubMed 29415592
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Subcutaneous Tissue Closure Technique in Cesarean Section on Reducing Postoperative Wound Complications
- ClinicalTrials.gov ID
- NCT03354078
- Acronym / sponsor ID
- Cesarean section / sutures
- Conditions
- Cesarean Section
- Keywords
- Cesarean section, Wound infection, Gapping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Study start
- 18 Jun 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 23 Nov 2017 (actual)
- First posted
- 27 Nov 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.
Only a small number of research studies evaluated the impact of various subcutaneous tissue and skin closure methods at cesarean section. In a meta-analysis a major decline in incision site rupture was revealed when suturing the subcutaneous tissue in women with a subcutaneous depth >2 cm.
Detailed description
Postoperative wound complications are one of the great issues in cesarean section (CS) with an incidence ranging from 3% to 30%.1 Obesity, operative time, diabetes, age of the patient, anemia, associated infection (e.g chorioamnionitis), the use of internal monitoring, delayed labor with many vaginal examinations and reduced nutrition are recognized risk factors for wound infections.
Evaluating the various techniques for closure of the subcutaneous layer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interrupted sutures group | Active comparator | Procedure: interrupted sutures, Procedure: continous suturesThis group in which closure of the subcutaneous layer is closed by interrupted sutures |
| Continous sutures group | Active comparator | Procedure: interrupted sutures, Procedure: continous suturessubcutanous tissue layer is closed by continous sutures in this group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All patients included in this research BMI ≥ 30, First cesarean section performed, no medical disorders with pregnancy e.g DM, HTN. All patients were subjected to full history taking, examination.
- depth of subcutaneous tissue estimated by a special device used (sterilized operative ruler). number of sutures estimation
Key exclusion criteria (1 listed)
- The following patients were excluded BMI <30, Previous CS, DM with pregnancy, HTN with pregnancy
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 suturesThe way of closing subcutaneous tissue either by interrupted | Procedure or surgery | Continous sutures group, interrupted sutures group |
| continous suturesThe way of closure of subcutanous tissue is by continous sutures | Procedure or surgery | Continous sutures group, interrupted sutures group |
Primary outcome
The number of participants who passed without postoperative complications
Time frame: one month post cesarean section
Describes how many participant willnot complain from wound seroma , wound erythema and wound infection
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 5 Apr 2022.
- Derived from this study: PubMed 29415592Alalfy M, Elgazzar A, Fares T, Nagy O, Ellithy A, Lasheen Y, Kamel A, Soliman M, Hassan A, Samy A, Taher AM, Ogila AI, Saad H, Salah H, Ramadan M, Nabil M, Hatem DL, Fikry M. Effect of subcutaneous tissue closure technique in cesarean section on postoperative wound complications in obese Egyptian women. J Matern Fetal Neonatal Med. 2019 Aug;32(15):2452-2459. doi: 10.1080/14767058.2018.1438399. Epub 2018 Feb 20.
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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.
Mahmoud Alalfy, M.s.c study chair
Algazeerah hospital -Location (Giza -Egypt )
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 sutures and continous sutures in people with Cesarean Section, run by Aljazeera Hospital 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 2 inclusion and 1 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 5 Apr 2022. 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?
The number of participants who passed without postoperative complications (time frame: one month post cesarean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03354078, which also lists 1 linked publication.
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 5 Apr 2022.