An interventional study of Subcutaneous Drain in Cesarean Section, sponsored by Menoufia University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-02-22.
Sponsored by Menoufia University · Not applicable, Interventional, and Prevention
A randomized controlled trial that aimed at studying the values (if any) of subcutaneous drains use in lean women during Cesarean section.
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.
Menoufia University is the lead sponsor of 192 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria: In order to control any confounding variables, we will exclude women with an added risk of wound complications. Those will include:
Patients for whom a subcutaneous drain was used
Procedure: Subcutaneous Drain
No drain group
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.
Rate of superficial surgical site infection
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
Time frame: within 72 hours after the operation
Wound seroma
A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery
Time frame: up to 6 weeks postoperative
Superficial wound breakdown
superficial wound breakdown (defined as skin and/or subcutaneous dehiscence with intact fascial layer)
Time frame: up to 6 weeks postoperative
Postoperative fever
temperature 38 C, 24 hours postoperatively
Time frame: 24 hours postoperatively
Postoperative pain
through visual analogue scale (VAS); with 0 meaning no pain, and 10 meaning the worst pain
Time frame: after 24 hours postoperative
Plan to share: Undecided
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Menoufia University