CClinicalTrials.gg
CompletedNCT03114332Updated Feb 22, 2019

Subcutaneous Drains And Cesarean Section

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

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

A randomized controlled trial that aimed at studying the values (if any) of subcutaneous drains use in lean women during Cesarean section.

Read the 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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Conditions studied

  • Cesarean Section
03

In context

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Study Group

    Patients for whom a subcutaneous drain was used

    Procedure: Subcutaneous Drain

  • No intervention
    Control group

    No drain group

Interventions

  • ProcedureSubcutaneous 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.

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Superficial wound breakdown

    superficial wound breakdown (defined as skin and/or subcutaneous dehiscence with intact fascial layer)

    Time frame: up to 6 weeks postoperative

  3. Postoperative fever

    temperature 38 C, 24 hours postoperatively

    Time frame: 24 hours postoperatively

  4. Postoperative pain

    through visual analogue scale (VAS); with 0 meaning no pain, and 10 meaning the worst pain

    Time frame: after 24 hours postoperative

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Study locations

1 site
  • Department of Obstetrics and Gynecology - Faculty of Medicine - Menoufia University
    Shibin al Kawm, EL Menofia 32651, Egypt
08

References and documents

Publications

  • 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. PubMed 11961377 ↗
  • Gates S, Anderson ER. Wound drainage for caesarean section. Cochrane Database Syst Rev. 2013 Dec 13;(12):CD004549. doi: 10.1002/14651858.CD004549.pub3. PubMed 24338262 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03114332
Lead sponsor
Menoufia University
Responsible party
Haitham Aboali Hamza (Lecturer of Obstetrics and Gynecology, Menoufia University) — Principal investigator
First posted
Apr 14, 2017
Start date
Dec 2015
Primary completion
Aug 2016
Completion
Sep 2016
Last update
Feb 22, 2019

Study contacts

HAITHAM A HAMZA, MD
principal investigator · Menoufia University - Egypt
Ibrahim A Seif El Nasr, MD
principal investigator · Menoufia University - Egypt
Nabih I Elkhouly, MD
principal investigator · Menoufia University - Egypt

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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