ClinicalTrials.gg
CompletedNCT03321175Updated Apr 4, 2018

Evaluation the Impact of Subcutaneous Irrigation on Wound Complications

An interventional study of subcutaneous saline irrigation in Cesarean Section; Complications, Wound, Hematoma, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-04-04.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
185
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

to evaluate the effect of subcutaneous irrigation on wound complications

Read the detailed description

Cesarean section is the most common abdominal operation performed worldwide. As with every other surgical procedure, it is sometimes accompanied by surgical complications. Wound complications are encountered in approximately 5% of women that undergo CS and include haematomas, seromas and infection. To evaluate the effects and benefits of subcutaneous irrigation during cesarean section we decide to conduct this randomized study.

02

Conditions studied

  • Cesarean Section; Complications, Wound, Hematoma

Keywords

  • Wound
  • infection
  • cesarean section
03

In context

Wounds and Injuries

2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.

This study's enrollment of 185 is above the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 225 studies on the registry; 35 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

  • Age 18-40, undergoing cesarean section

Exclusion criteria

Exclusion Criteria:

  • patients with systemical disease, >30
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.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
185 participants (actual)

Study arms

  • Experimental
    Subcutaneous irrigaton

    Patients will receive 200 cc subcutaneous saline irrigation before skin incision closure.

    Other: subcutaneous saline irrigation

  • No intervention
    Subcutaneous no irrigation

    Patients will not receive subcutaneous saline irrigation before skin incision closure.

Interventions

  • Othersubcutaneous saline irrigation

    200 cc saline irrigation

06

What researchers measure

Primary outcomes

  1. wound complications

    wound complications will be evaluated 1 week after the surgery.

    Time frame: 1 week

07

Study locations

1 site
  • Kanuni SSTRH
    İstanbul, Turkey
08

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 Oct 2017 to primary completion in Mar 2018, 5 months.

Of 546 non-industry interventional studies with no phase under Wounds and Injuries, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 49. This study's 5 months is below that.

Counting every sponsor, half of 599 studies reached it within 24 months; a quarter within 9 and three quarters within 48.

Wounds and Injuries covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

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

Registered
Oct 22, 2017
First posted
Oct 25, 2017
StartActual
Oct 23, 2017
Primary completionActual
Mar 30, 2018
CompletionActual
Mar 30, 2018
Last update
Apr 4, 2018
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 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03321175
Responsible party
Berna Aslan Cetin (Attending physician,ObGyn, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Oct 25, 2017
Start date
Oct 23, 2017
Primary completion
Mar 30, 2018
Completion
Mar 30, 2018
Last update
Apr 4, 2018

Oversight

Data monitoring committee
No
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 2018. You cannot join it, but the record below documents what was studied.

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