NCT03114332

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

April 5, 2017

Last Update Submit

February 21, 2019

Conditions

Cesarean Section

Outcome Measures

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

    within 72 hours after the operation

Secondary Outcomes (4)

  • Wound seroma

    up to 6 weeks postoperative

  • Superficial wound breakdown

    up to 6 weeks postoperative

  • Postoperative fever

    24 hours postoperatively

  • Postoperative pain

    after 24 hours postoperative

Study Arms (2)

Study Group

EXPERIMENTAL

Patients for whom a subcutaneous drain was used

Procedure: Subcutaneous Drain

Control group

NO INTERVENTION

No drain group

Interventions

Subcutaneous DrainPROCEDURE

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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology - Faculty of Medicine - Menoufia University

Shibīn al Kawm, EL Menofia, 32651, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 11961377BACKGROUND

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

    PMID: 24338262BACKGROUND

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics and Gynecology

Study Record Dates

First Submitted

April 5, 2017

First Posted

April 14, 2017

Study Start

December 1, 2015

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

February 22, 2019

Record last verified: 2019-02

Locations

EG(1)