NCT03321175

Brief Summary

to evaluate the effect of subcutaneous irrigation on wound complications

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

October 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
Last Updated

April 4, 2018

Status Verified

April 1, 2018

Enrollment Period

5 months

First QC Date

October 22, 2017

Last Update Submit

April 3, 2018

Conditions

Cesarean Section; Complications, Wound, Hematoma

Keywords

Woundinfectioncesarean section

Outcome Measures

Primary Outcomes (1)

  • wound complications

    wound complications will be evaluated 1 week after the surgery.

    1 week

Study Arms (2)

Subcutaneous irrigaton

EXPERIMENTAL

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

Other: subcutaneous saline irrigation

Subcutaneous no irrigation

NO INTERVENTION

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

Interventions

subcutaneous saline irrigationOTHER

200 cc saline irrigation

Subcutaneous irrigaton

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients undergoing cesarean section
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-40, undergoing cesarean section

You may not qualify if:

  • patients with systemical disease, body mass index\>30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni SSTRH

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Wounds and InjuriesHematomaInfections

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician,ObGyn

Study Record Dates

First Submitted

October 22, 2017

First Posted

October 25, 2017

Study Start

October 23, 2017

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

April 4, 2018

Record last verified: 2018-04

Locations

TU(1)