Evaluation the Impact of Subcutaneous Irrigation on Wound... | NCT03321175

Studies
Evaluation the Impact of Subcutaneous Irrigation on Wound Complications

NCT03321175

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Status

Completed

Last Update Posted

Apr 4, 2018Actual

Enrollment

185Actual

Phase

Not Applicable

Conditions

Cesarean Section; Complications, Wound, Hematoma

Interventions

subcutaneous saline irrigation

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 23, 2017Actual

Primary Completion Date

Mar 30, 2018Actual

Completion Date

Mar 30, 2018Actual

First Submitted Date

Oct 22, 2017

First Submission Date that Met QC Criteria

Oct 22, 2017

First Posted Date

Oct 25, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2018

Last Update Posted Date

Apr 4, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Berna Aslan Cetin, Attending physician,ObGyn, Kanuni Sultan Suleyman Training and Research HospitalPrincipal Investigator

Lead Sponsor

Kanuni Sultan Suleyman Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

185Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
subcutaneous saline irrigation	Other	200 cc saline irrigation	Subcutaneous irrigaton

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
wound complications	wound complications will be evaluated 1 week after the surgery.	1 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-40, undergoing cesarean section

Exclusion Criteria:

patients with systemical disease, body mass index>30

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Patients undergoing cesarean section

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kanuni SSTRH		Istanbul			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries
D006406	Hematoma
D007239	Infections

Ancestor Terms

ID	Term
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided