Status:

COMPLETED

External Negative Pressure Dressing System vs. Traditional Wound Dressing for Cesarean Section Incision in Obese Women.

Lead Sponsor:

Ain Shams Maternity Hospital

Conditions:

Wound Dehiscence

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

Obesity is associated with increased cesarean section delivery rates and surgical site infections with associated increased post-operative morbidity, post-operative pain and length of hospital stay. ...

Detailed Description

Obesity, defined as body mass index (BMI, calculated as weight (kg)/ \[height (m)\] 2) of 30 or greater, is a common medical comorbidity of pregnancy affecting one third of reproductive-aged women. Ma...

Eligibility Criteria

Inclusion

  • Age: 18 or older
  • BMI: 30 or greater
  • undergoing Cesarean section through a Pfannenstiel incision

Exclusion

  • Prolonged Rupture of membranes \>18 hours
  • Intra amniotic infection
  • Severe anemia
  • Vasculopathies as in hypertension/pre-eclampsia, pregestational / gestational diabetes mellitus, smoking and substance abuse
  • Prolonged steroids therapy as in SLE, ITP
  • Intraoperative complications as bladder or bowel injury , placenta previa / accreta, difficult fetal extraction , ovarian cysts, pelvic abscess
  • Intra-abdominal or subcutaneous drain

Key Trial Info

Start Date :

August 3 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 4 2021

Estimated Enrollment :

260 Patients enrolled

Trial Details

Trial ID

NCT04434820

Start Date

August 3 2020

End Date

February 4 2021

Last Update

February 18 2021

Active Locations (1)

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AinShams maternity hospital

Cairo, Al-Waili, Egypt, 11658