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Evaluation the Impact of Subcutaneous Irrigation on Wound Complications

Primary Purpose

Cesarean Section; Complications, Wound, Hematoma

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
subcutaneous saline irrigation
Sponsored by
Kanuni Sultan Suleyman Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Section; Complications, Wound, Hematoma focused on measuring Wound, infection, cesarean section

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-40, undergoing cesarean section

Exclusion Criteria:

  • patients with systemical disease, body mass index>30

Sites / Locations

  • Kanuni SSTRH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Subcutaneous irrigaton

Subcutaneous no irrigation

Arm Description

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

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

Outcomes

Primary Outcome Measures

wound complications
wound complications will be evaluated 1 week after the surgery.

Secondary Outcome Measures

Full Information

First Posted
October 22, 2017
Last Updated
April 3, 2018
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03321175
Brief Title
Evaluation the Impact of Subcutaneous Irrigation on Wound Complications
Official Title
Evaluation the Impact of Subcutaneous Irrigation on Wound Complications
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
March 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section; Complications, Wound, Hematoma
Keywords
Wound, infection, cesarean section

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subcutaneous irrigaton
Arm Type
Experimental
Arm Description
Patients will receive 200 cc subcutaneous saline irrigation before skin incision closure.
Arm Title
Subcutaneous no irrigation
Arm Type
No Intervention
Arm Description
Patients will not receive subcutaneous saline irrigation before skin incision closure.
Intervention Type
Other
Intervention Name(s)
subcutaneous saline irrigation
Intervention Description
200 cc saline irrigation
Primary Outcome Measure Information:
Title
wound complications
Description
wound complications will be evaluated 1 week after the surgery.
Time Frame
1 week

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patients undergoing cesarean section
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-40, undergoing cesarean section Exclusion Criteria: patients with systemical disease, body mass index>30
Facility Information:
Facility Name
Kanuni SSTRH
City
İstanbul
Country
Turkey

12. IPD Sharing Statement

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Evaluation the Impact of Subcutaneous Irrigation on Wound Complications

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