Cesarean Section; Complications, Wound, HematomaNCT03321175
Evaluation the Impact of Subcutaneous Irrigation on Wound Complications
A study testing subcutaneous saline irrigation in people with Cesarean Section; Complications, Wound, Hematoma, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
to evaluate the effect of subcutaneous irrigation on wound complications Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section; Complications, Wound, Hematoma
- What is being tested?
- subcutaneous saline irrigation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Oct 2017to 30 Mar 2018
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-40, undergoing cesarean section
Who cannot join
- patients with systemical disease, body mass index>30
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- subcutaneous saline irrigation
- Keywords
- Wound, infection, cesarean section
- Medical subject headings
- Wounds and Injuries, Hematoma, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcutaneous saline irrigationOther
200 cc saline irrigation
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous irrigaton | Experimental | Patients will receive 200 cc subcutaneous saline irrigation before skin incision closure. Receives: Other: subcutaneous saline irrigation |
| Subcutaneous no irrigation | No intervention | Patients will not receive subcutaneous saline irrigation before skin incision closure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound complications
wound complications will be evaluated 1 week after the surgery.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start23 Oct 2017
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section; Complications, Wound, HematomaStudies 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
- Model description
- Randomization will be performed by an online software. Randomized cards will be in sealed envelopes and will be open by surgeon at the time of surgery.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321175
- Sponsor's protocol ID
- 2017/219
- Status last verified
- Apr 2018
- First submitted
- 22 Oct 2017
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Impact of Subcutaneous Irrigation on Wound Complications
- ClinicalTrials.gov ID
- NCT03321175
- Acronym / sponsor ID
- 2017/219
- Keywords
- Wound, infection, cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 25 Oct 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.
to evaluate the effect of subcutaneous irrigation on wound complications
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomization will be performed by an online software. Randomized cards will be in sealed envelopes and will be open by surgeon at the time of surgery.
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous irrigaton | Experimental | Other: subcutaneous saline irrigationPatients will receive 200 cc subcutaneous saline irrigation before skin incision closure. |
| Subcutaneous no irrigation | No intervention | –Patients will not receive subcutaneous saline irrigation before skin incision closure. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 18-40, undergoing cesarean section
Key exclusion criteria (1 listed)
- patients with systemical disease, body mass index>30
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 |
|---|---|---|
| subcutaneous saline irrigation200 cc saline irrigation | Other | Subcutaneous irrigaton |
Primary outcome
wound complications
Time frame: 1 week
wound complications will be evaluated 1 week after the 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 4 Apr 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subcutaneous saline irrigation in people with Cesarean Section; Complications, Wound, Hematoma, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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 4 Apr 2018. 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 Turkey (Türkiye). 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 complications (time frame: 1 week). 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 4 Apr 2018.