Subcutaneous Drains And Cesarean Section

Not Applicable

Completed

• Conditions: Cesarean Section
• Interventions: Procedure: Subcutaneous Drain

• Registration Number: NCT03114332
• Lead Sponsor: Menoufia University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-12
• Primary Completion: 2016-08
• Study Completion: 2016-09
• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Subcutaneous Drain	Patients for whom a subcutaneous drain was used

Primary Outcome Measures

Name	Time	Method
Rate of superficial surgical site infection	within 72 hours after the operation	rate of superficial surgical site infection, defined as presence of wound discharge that yielded a positive result on bacteriological culture within 72 hours after the operation

Secondary Outcome Measures

Name	Time	Method
Postoperative fever	24 hours postoperatively	temperature 38 C, 24 hours postoperatively
Superficial wound breakdown	up to 6 weeks postoperative	superficial wound breakdown (defined as skin and/or subcutaneous dehiscence with intact fascial layer)
Postoperative pain	after 24 hours postoperative	through visual analogue scale (VAS); with 0 meaning no pain, and 10 meaning the worst pain
Wound seroma	up to 6 weeks postoperative	A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology - Faculty of Medicine - Menoufia University; 🇪🇬 Shibin al Kawm, EL Menofia, Egypt