ClinicalTrials.gg
CompletedNCT03354078Updated Apr 5, 2022

Effect of Subcutaneous Tissue Closure on Wound Complications

An interventional study of interrupted sutures and continous sutures in Cesarean Section, sponsored by Aljazeera Hospital. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-05.

Sponsored by Aljazeera Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jun 2017, registered Nov 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
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Study 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 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.

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Conditions studied

  • Cesarean Section

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Keywords

  • Cesarean section
  • Wound infection
  • Gapping
03

In context

Wound Infection

270 studies on the registry are indexed under Wound Infection; 33 are open to participants now.

This study's enrollment of 400 is above the median of 141 across 228 interventional studies indexed under Wound Infection.

Browse Wound Infection studies →

Lead sponsor

Aljazeera Hospital is the lead sponsor of 64 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients included in this research ≥ 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

Exclusion criteria

Exclusion Criteria:

  • The following patients were excluded \<30, Previous CS, DM with pregnancy, HTN with pregnancy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
400 participants (actual)

Study arms

  • Active comparator
    interrupted sutures group

    This group in which closure of the subcutaneous layer is closed by interrupted sutures

    Procedure: interrupted sutures · Procedure: continous sutures

  • Active comparator
    Continous sutures group

    subcutanous tissue layer is closed by continous sutures in this group

    Procedure: interrupted sutures · Procedure: continous sutures

Interventions

  • Procedureinterrupted sutures

    The way of closing subcutaneous tissue either by interrupted

  • Procedurecontinous sutures

    The way of closure of subcutanous tissue is by continous sutures

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What researchers measure

Primary outcomes

  1. The number of participants who passed without postoperative complications

    Describes how many participant willnot complain from wound seroma , wound erythema and wound infection

    Time frame: one month post cesarean section

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Study locations

1 site
  • Algazeerah
    Giza, Egypt
08

References and documents

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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2017 to primary completion in Nov 2017, 4 months.

Of 59 non-industry interventional studies with no phase under Wound Infection, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 53. This study's 4 months is below that.

Counting every sponsor, half of 64 studies reached it within 19 months; a quarter within 13 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2017
First posted
Nov 27, 2017
StartActual
Jun 18, 2017
Primary completionActual
Nov 1, 2017
CompletionActual
Nov 23, 2017
Last update
Apr 5, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03354078
Lead sponsor
Aljazeera Hospital
Responsible party
Sponsor
First posted
Nov 27, 2017
Start date
Jun 18, 2017
Primary completion
Nov 1, 2017
Completion
Nov 23, 2017
Last update
Apr 5, 2022

Study contacts

Mahmoud Alalfy, M.s.c
study chair · Algazeerah hospital -Location (Giza -Egypt )

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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