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

February 17, 2021 updated by: Dalia Magdy Mokhtar, Ain Shams Maternity Hospital

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

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.

Negative pressure wound therapy (NPWT) technology could be used as a prophylactic measure to reduce surgical site infections in obese women undergoing cesarean section by immediate postoperative application in clean-contaminated, closed surgical incisions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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. Maternal obesity is also a well-recognized risk factor for dysfunctional labor and cesarean delivery with a cesarean section rate of 33% in obese women with BMI of 30 or greater and 43% in women with BMIs of 40 or greater.

Obesity is an independent risk factor for post-operative surgical site infection. The risk of post-cesarean surgical site infection has been shown to double for every 5 unit increase in body mass index (BMI) above 30 kg/m , occurring in about 10% of obese women undergoing caesarean section despite prophylactic strategies (e.g. antibiotics).

This can be explained partly by a decreased blood flow in adipose tissue and an obesity-associated inflammation causing vascular dysfunction, which results in a local hypoxic response. Hypoxia impairs oxidative bacterial killing and leads to an increased risk of surgical site infection.

Wound healing is a sequence of physiologic events that include inflammation, epithelialization, fibroplasia, and maturation. Failure of wound healing at the surgical site can lead to seroma, hematoma, wound dehiscence, incisional hernia and surgical site infection.

Surgical site infection SSI according to The Centers for Disease Control and Prevention is as an infection occurring within 30 days from the operative procedure in the part of the body where the surgery took place, where there is purulent drainage from incision, isolated organisms from the incision, dehiscence or deliberate opening by the surgeon when the patient has at least one sign or symptom of clinical infection: localized pain, edema, erythema, warmth and fever greater than 38 c (unless culture of incision is negative) or there is an abscess or other evidence of infection is found during examination of incision, reoperation, or pathologic or radiologic exam.

SSIs is divided into incisional SSI and organ/space SSI. Incisional SSI is further divided into superficial and deep incisional SSI. Superficial Incisional Surgical Site Infection involves skin or subcutaneous tissue cellulitis, seroma, hematoma, wound healing disruption, or dehiscence. Deep Incisional Surgical Site Infection involves deep soft tissues such as fascia or muscle within incision. Organ/Space Surgical Site Infection involves any part of the anatomy other than the incision. SSI is associated with a maternal mortality rate of up to 3%.

Wound complication, even if not accompanied by an infection, is a significant cause of postoperative morbidity following cesarean delivery. In addition to the increased cost of care, there is the inconvenience of therapy, increased postoperative pain and convalescence, as well as difficulty with activities of daily living.

It is logical to employ novel risk reducing approaches including negative pressure wound therapy at the time of surgery that may prevent wound complications and to ensure that there is a demonstrable benefit to their use for wound complication prophylaxis.

Negative pressure wound therapy (NPWT), also known as a vacuum assisted closure (VAC), involves the controlled application of sub-atmospheric pressure to the local wound environment, using a sealed wound dressing connected to a vacuum to promote healing by primary intention by reducing the risk of hematoma / seroma due to improved lymphatic drainage and reduces the risk of wound dehiscence by decreasing the lateral and shear stress on sutures and decreasing bacterial load and wound fluids and by increasing blood flow, oxygenation, angiogenesis, and epithelialization.

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Al-Waili
      • Cairo, Al-Waili, Egypt, 11658
        • AinShams Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: standard dressing group
patients will receive sterile wound dressing of gauze and tape for 4 days.
Active Comparator: External negative pressure dressing system group
patients will receive placement of a sterile dressing of gauze and occlusive adhesive over the closed incision. The dressing's tubing will then be attached to a compact, portable negative-pressure therapy unit (Yuwell 7E-A portable suction unit) that will deliver -80 mm Hg of continuous pressure to the dressing and will remove exudates into a disposable canister for 4 days.
Device: External negative pressure dressing system (Yuwell 7E-A portable suction unit)
A portable suction unit that will deliver 125 mm Hg of continuous pressure to the dressing and will remove exudates into a disposable canister for 4 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of wound dehiscence
Time Frame: till 30 days post operative
separation of the incision line prior to complete healing resulting in an open wound.
till 30 days post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative pain
Time Frame: till 30 days post operative
post-operative pain assessed by Wong-Baker Faces pain rating scale,from 0=no pain to 10=maximal pain
till 30 days post operative
length of hospital stay
Time Frame: till 30 days post operative
days spent admitted to the hospital
till 30 days post operative
the need for re-admission
Time Frame: till 30 days post operative
if the patient encountered surgical site infection requiring re admission to the hospital
till 30 days post operative
further need for additional antibiotics
Time Frame: till 30 days post operative
if the surgical site infection required additional post operative antibiotics
till 30 days post operative
peri-incision blistering
Time Frame: till 30 days post operative
if any skin blistering occurs under the occlusive adhesive layer
till 30 days post operative
patient mobility
Time Frame: 4 days
if attachment to a negative pressure pump affects patients mobility
4 days
surgical site infection
Time Frame: 30 days post operative
as defined by the CDC
30 days post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Investigators

  • Principal Investigator: Dalia M Mokhtar, MBBCh, resident of obstetrics and gynecology
  • Study Director: Marwan O Elkady, MD, Lecturer of obstetrics and gynecology
  • Study Chair: Mohammed S El Sokkary, MD, Professor of Obstetrics and Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2020

Primary Completion (Actual)

February 3, 2021

Study Completion (Actual)

February 4, 2021

Study Registration Dates

First Submitted

June 14, 2020

First Submitted That Met QC Criteria

June 16, 2020

First Posted (Actual)

June 17, 2020

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 642357

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

patient's age ,ethnicity,gravidity,parity,gestational age ,previous cesarean section, previous surgeries,weight, height,BMI,pre/post operative haemoglobin,degree of post operative pain,incidence and type of surgical site infection,length of hospital stay, need for re-admission,need for additional antibiotics

IPD Sharing Time Frame

after completing the study and henceforth .

IPD Sharing Access Criteria

everyone can review the IPD on this site for any type of analysis they desire .

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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