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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03114332
Date of registration:	05/04/2017
Prospective Registration:	No
Primary sponsor:	Menoufia University
Public title:	Subcutaneous Drains And Cesarean Section
Scientific title:	Subcutaneous Drains In Lean Women Undergoing Cesarean Section, A Randomized Controlled Trial
Date of first enrolment:	December 2015
Target sample size:	150
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03114332
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Investigator).
Phase:	N/A

Countries of recruitment
Egypt

Contacts

Name:	Nabih I Elkhouly, MD
Address:
Telephone:
Email:
Affiliation:	Menoufia University - Egypt

Name:	HAITHAM A HAMZA, MD
Address:
Telephone:
Email:
Affiliation:	Menoufia University - Egypt

Name:	Ibrahim A Seif El Nasr, MD
Address:
Telephone:
Email:
Affiliation:	Menoufia University - Egypt

Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Cesarean Section

Intervention(s)

Procedure: Subcutaneous Drain

Primary Outcome(s)

Rate of superficial surgical site infection [Time Frame: within 72 hours after the operation]

Secondary Outcome(s)

Postoperative fever [Time Frame: 24 hours postoperatively]

Wound seroma [Time Frame: up to 6 weeks postoperative]

Postoperative pain [Time Frame: after 24 hours postoperative]

Superficial wound breakdown [Time Frame: up to 6 weeks postoperative]

Secondary ID(s)

MU112

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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