Subcutaneous Drains And Cesarean Section
|ClinicalTrials.gov Identifier: NCT03114332|
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : February 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cesarean Section||Procedure: Subcutaneous Drain||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Subcutaneous Drains In Lean Women Undergoing Cesarean Section, A Randomized Controlled Trial|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||September 2016|
Experimental: Study Group
Patients for whom a subcutaneous drain was used
Procedure: 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.
No Intervention: Control group
No drain group
- Rate of superficial surgical site infection [ Time Frame: 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
- Wound seroma [ Time Frame: up to 6 weeks postoperative ]A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery
- Superficial wound breakdown [ Time Frame: up to 6 weeks postoperative ]superficial wound breakdown (defined as skin and/or subcutaneous dehiscence with intact fascial layer)
- Postoperative fever [ Time Frame: 24 hours postoperatively ]temperature 38 C, 24 hours postoperatively
- Postoperative pain [ Time Frame: after 24 hours postoperative ]through visual analogue scale (VAS); with 0 meaning no pain, and 10 meaning the worst pain
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114332
|Department of Obstetrics and Gynecology - Faculty of Medicine - Menoufia University|
|Shibin al Kawm, EL Menofia, Egypt, 32651|
|Principal Investigator:||HAITHAM A HAMZA, MD||Menoufia University - Egypt|
|Principal Investigator:||Ibrahim A Seif El Nasr, MD||Menoufia University - Egypt|
|Principal Investigator:||Nabih I Elkhouly, MD||Menoufia University - Egypt|