Subcutaneous Drains And Cesarean Section

NCT ID: NCT03114332

Last Updated: 2019-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-09-30

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.

Conditions

Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Study Group

Patients for whom a subcutaneous drain was used

Group Type: EXPERIMENTAL

Subcutaneous Drain

Intervention Type: PROCEDURE

A closed drainage system for the subcutaneous tissue was used (Redivac) through a separate stab wound. Drains were left in place for 24 h or until drainage was less than 50 ml.

Control group

No drain group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Subcutaneous Drain

A closed drainage system for the subcutaneous tissue was used (Redivac) through a separate stab wound. Drains were left in place for 24 h or until drainage was less than 50 ml.

Intervention Type: PROCEDURE

Eligibility 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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Haitham Aboali Hamza

Lecturer of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

HAITHAM A HAMZA, MD

Role: PRINCIPAL_INVESTIGATOR

Menoufia University - Egypt

Ibrahim A Seif El Nasr, MD

Role: PRINCIPAL_INVESTIGATOR

Menoufia University - Egypt

Nabih I Elkhouly, MD

Role: PRINCIPAL_INVESTIGATOR

Menoufia University - Egypt

Locations

Department of Obstetrics and Gynecology - Faculty of Medicine - Menoufia University

Shibīn al Kawm, EL Menofia, Egypt

Countries

Egypt

References

Al-Inany H, Youssef G, Abd ElMaguid A, Abdel Hamid M, Naguib A. Value of subcutaneous drainage system in obese females undergoing cesarean section using pfannenstiel incision. Gynecol Obstet Invest. 2002;53(2):75-8. doi: 10.1159/000052996.

Reference Type: BACKGROUND

PMID: 11961377 (View on PubMed)

Gates S, Anderson ER. Wound drainage for caesarean section. Cochrane Database Syst Rev. 2013 Dec 13;2013(12):CD004549. doi: 10.1002/14651858.CD004549.pub3.

Reference Type: BACKGROUND

PMID: 24338262 (View on PubMed)

Other Identifiers

MU112

Identifier Type: -

Identifier Source: org_study_id