Cesarean SectionNCT03114332
Subcutaneous Drains And Cesarean Section
A study testing Subcutaneous Drain in people with Cesarean Section, run by Menoufia University at 1 site in Egypt.
Trial summary
A randomized controlled trial that aimed at studying the values (if any) of subcutaneous drains use in lean women during Cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Subcutaneous Drain
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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:
- Diabetic women (as determined by fasting blood sugar and 2-hour Post prandial blood glucose).
- Morbid obese women (those with body mass index more than 35).
- Smokers and alcoholics.
- Immunocompromised women: AIDS patients and those receiving immunosuppressant agents.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Obstetrics and Gynecology - Faculty of Medicine - Menoufia University
Shibīn al Kawm, EL Menofia, 32651
About this study
Official title: Subcutaneous Drains In Lean Women Undergoing Cesarean Section, A Randomized Controlled Trial
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.
- Conditions
- Cesarean Section
- Being tested
- Subcutaneous Drain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous DrainProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Patients for whom a subcutaneous drain was used Receives: Procedure: Subcutaneous Drain |
| Control group | No intervention | No drain group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 72 hours after the operation
Secondary outcomes (4)
Wound seroma
A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery
Measured: up to 6 weeks postoperative
Superficial wound breakdown
superficial wound breakdown (defined as skin and/or subcutaneous dehiscence with intact fascial layer)
Measured: up to 6 weeks postoperative
Postoperative fever
temperature 38 C, 24 hours postoperatively
Measured: 24 hours postoperatively
Postoperative pain
through visual analogue scale (VAS); with 0 meaning no pain, and 10 meaning the worst pain
Measured: after 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study startDec 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haitham Aboali Hamza, Menoufia University
- Investigators
- HAITHAM A HAMZA, MD, Principal investigator, Menoufia University - EgyptIbrahim A Seif El Nasr, MD, Principal investigator, Menoufia University - EgyptNabih I Elkhouly, MD, Principal investigator, Menoufia University - Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114332
- Sponsor's protocol ID
- MU112
- Status last verified
- Feb 2019
- First submitted
- 5 Apr 2017
- Last updated
- 22 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 11961377Gates S, Anderson ER. Wound drainage for caesarean section. Cochrane Database Syst Rev. 2013 Dec 13;2013(12):CD004549. doi: 10.1002/14651858.CD004549.pub3.
PubMed 24338262
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Drains In Lean Women Undergoing Cesarean Section, A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03114332
- Acronym / sponsor ID
- MU112
- Conditions
- Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Procedure: Subcutaneous DrainPatients for whom a subcutaneous drain was used |
| Control group | No intervention | –No drain group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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:
- Diabetic women (as determined by fasting blood sugar and 2-hour Post prandial blood glucose).
- Morbid obese women (those with body mass index more than 35).
- Smokers and alcoholics.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcutaneous DrainA 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. | Procedure or surgery | Study Group |
Primary outcome
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
4 secondary outcomes
Wound seroma
Time frame: up to 6 weeks postoperative
Superficial wound breakdown
Time frame: up to 6 weeks postoperative
Postoperative fever
Time frame: 24 hours postoperatively
Postoperative pain
Time frame: after 24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Background: PubMed 11961377Al-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.
- Background: PubMed 24338262Gates S, Anderson ER. Wound drainage for caesarean section. Cochrane Database Syst Rev. 2013 Dec 13;2013(12):CD004549. doi: 10.1002/14651858.CD004549.pub3.
- Individual participant dataSharing planned: Undecided
Related trials for Cesarean Section
RecruitingObservational study
Prevalence of Pain During Cesarean Section
Cesarean Birth
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Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
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Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
RecruitingPhase 4
Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
Cesarean Delivery, Cesarean Delivery; Neuraxial Opioids
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Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous Drain in people with Cesarean Section, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of superficial surgical site infection (time frame: within 72 hours after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03114332, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.