Subcutaneous Drains And Cesarean Section

Menoufia University

Status: Completed

Conditions: Cesarean Section

Treatments: Procedure: Subcutaneous Drain

Study type: Interventional

Funder types: Other

Identifiers

NCT03114332

MU112

Details and patient eligibility

About

A randomized controlled trial that aimed at studying the values (if any) of subcutaneous drains use in lean women during Cesarean section.

Full description

Cesarean section (CS) is one of the most common operative procedures performed in modern obstetrics. Despite being that, common, surgical techniques and steps do widely vary. These variations depend on many factors including surgeons preferences, patient s characteristics and available facilities and circumstances .

The most common complications of Cesarean section are superficial surgical site complications including sepsis, seroma formation and breakdown.

One of the common, yet debatable, practices in Cesarean section is to use a subcutaneous drain for the wound .The advantage of such a practice is to drain any blood or serous fluid that may accumulate in the subcutaneous space, which cause post-operative pain or provide a good medium for microbial growth and infection.

Thus, it is assumed that drains can reduce the burden of surgical site infection. Some surgeons, however, have raised much argument about the value of subcutaneous drains and emerging evidence raised concerns about its effectiveness. Despite this, it is evident that it is still widely used in the clinical practice.

Most randomized controlled trials on this issue, from which we draw the current evidence, were conducted in the developed countries, mainly the United States, with readily available facilities and optimum level of care. This fact raises concerns about how this evidence can be applicable in developing countries with weak health care systems and low level of awareness. In addition, Cesarean section rates are greatly higher in developing countries due to its abuse, which emphasize how the current evidence can't be applicable and in need for further updates .

The current gap between the current practice and lack of evidence has to be filled. In this study, investigators aim at providing answers for this critical issue, thus investigators can ensure women's health and provide the best quality of care following Cesarean section.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. All females with previous cesarean sections admitted to Obstetrics and Gynecology Department at Menoufia University Hospitals either for elective or urgent cesarean section will be considered eligible.

Exclusion Criteria: In order to control any confounding variables, we will exclude women with an added risk of wound complications. Those will include:

1. Diabetic women (as determined by fasting blood sugar and 2-hour Post prandial blood glucose).
2. Morbid obese women (those with body mass index more than 35).
3. Smokers and alcoholics.
4. Immunocompromised women: AIDS patients and those receiving immunosuppressant agents.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Study Group

Experimental group

Description:

Patients for whom a subcutaneous drain was used

Treatment:

Procedure: Subcutaneous Drain

Control group

No Intervention group

Description:

No drain group