Evaluation the Impact of Subcutaneous Irrigation on Wound Complications

NCT ID: NCT03321175

Last Updated: 2018-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-23

Study Completion Date

2018-03-30

Brief Summary

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to evaluate the effect of subcutaneous irrigation on wound complications

Detailed Description

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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.

Conditions

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Cesarean Section; Complications, Wound, Hematoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Subcutaneous irrigaton

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

Group Type EXPERIMENTAL

subcutaneous saline irrigation

Intervention Type OTHER

200 cc saline irrigation

Subcutaneous no irrigation

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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subcutaneous saline irrigation

200 cc saline irrigation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18-40, undergoing cesarean section

Exclusion Criteria

* patients with systemical disease, body mass index\>30
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Berna Aslan Cetin

Attending physician,ObGyn

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kanuni SSTRH

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2017/219

Identifier Type: -

Identifier Source: org_study_id

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