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Subcutaneous Drains And Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03114332
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Haitham Aboali Hamza, 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.

Condition or disease Intervention/treatment Phase
Cesarean Section Procedure: Subcutaneous Drain Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Superficial wound breakdown [ Time Frame: up to 6 weeks postoperative ]
    superficial wound breakdown (defined as skin and/or subcutaneous dehiscence with intact fascial layer)

  3. Postoperative fever [ Time Frame: 24 hours postoperatively ]
    temperature 38 C, 24 hours postoperatively

  4. Postoperative pain [ Time Frame: after 24 hours postoperative ]
    through visual analogue scale (VAS); with 0 meaning no pain, and 10 meaning the worst pain



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114332


Locations
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Egypt
Department of Obstetrics and Gynecology - Faculty of Medicine - Menoufia University
Shibin al Kawm, EL Menofia, Egypt, 32651
Sponsors and Collaborators
Menoufia University
Investigators
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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
Publications:
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Responsible Party: Haitham Aboali Hamza, Lecturer of Obstetrics and Gynecology, Menoufia University
ClinicalTrials.gov Identifier: NCT03114332    
Other Study ID Numbers: MU112
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No