Clinical trial NCT03114332: Subcutaneous Drains And Cesarean Section
Official title: Subcutaneous Drains In Lean Women Undergoing Cesarean Section, A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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: 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.

Primary outcomes:
measure: Rate of superficial surgical site infection
timeFrame: within 72 hours after the operation
Secondary outcomes:
measure: Wound seroma
timeFrame: up to 6 weeks postoperative
measure: Superficial wound breakdown
timeFrame: up to 6 weeks postoperative
measure: Postoperative fever
timeFrame: 24 hours postoperatively
measure: Postoperative pain
timeFrame: after 24 hours postoperative
Other outcomes:
Locations:
city: Shibin al Kawm
country: Egypt
facility: Department of Obstetrics and Gynecology - Faculty of Medicine - Menoufia University
state: EL Menofia
Study officials:
affiliation: Menoufia University - Egypt
name: HAITHAM A HAMZA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Menoufia University - Egypt
name: Ibrahim A Seif El Nasr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Menoufia University - Egypt
name: Nabih I Elkhouly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Gates S, Anderson ER. Wound drainage for caesarean section. Cochrane Database Syst Rev. 2013 Dec 13;(12):CD004549. doi: 10.1002/14651858.CD004549.pub3.