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Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01890720
First Posted: July 2, 2013
Last Update Posted: January 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Region of Southern Denmark
University of Southern Denmark
Hvidovre University Hospital
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Nana Hyldig, Odense University Hospital
  Purpose
The purpose of this study is to examine whether obese women (BMI >= 30) who give birth by caesarean section have a reduced incidence of wound infection and dehiscence when incisional Negative Pressure Wound Therapy is applied prophylactically following caesarean section.

Condition Intervention
Surgical Wound Infection Infection; Cesarean Section Cesarean Section; Dehiscence Complications; Cesarean Section Complications; Cesarean Section, Wound, Dehiscence Wound; Rupture, Surgery, Cesarean Section Device: iNPWT Other: Standard postoperative wound dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Use of Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section in Women With BMI >=30

Resource links provided by NLM:


Further study details as provided by Nana Hyldig, Odense University Hospital:

Primary Outcome Measures:
  • The incidence of post-CS wound infection in each study group [ Time Frame: Within the first 30 days after surgery ]

    Wound infection requiring antibiotic treatment

    To be able to collect information about symptoms of infection after discharge a self-administered questionnaire will be sent to all participants within 30 days post-CS. Furthermore data on postoperative infections, recorded by diagnoses codes or surgical procedures, will be obtained from the Danish National Patient Registry



Secondary Outcome Measures:
  • Length of the primary and any secondary hospitalization [ Time Frame: Within the first 30 days after Caesarean Section ]
    Primary for the health economic evaluation

  • Readmissions to hospital/contact to the general practitioner on suspicion of infection following caesarean section [ Time Frame: Within the first 30 days after Caesarean Section ]
    Primary for the health economic evaluation

  • Number of Participants with a decreased health-related quality of life score as a measure of satisfaction and tolerability [ Time Frame: Within the first 30 days after Caesarean Section ]
    A health-related quality of life measure, recorded in Quality Adjusted Life Years at the two interventions. The health-related quality of life score is measured 5 and 30 days post-CS. Primary for the health economic evaluation

  • Antibiotic treatment on suspicion of infection after Caesarean Section [ Time Frame: Within the first 30 days after Caesarean Section ]
    Primary for the health economic evaluation

  • The cosmetic outcome as a measure of satisfaction [ Time Frame: A 6 and 12 months follow-up ]
    The scar will be evaluated by a plastic surgeon at a clinical examination 6 and 12 months post-CS. After study completion pictures of the scars will be evaluated by two unbiased plastic surgeons, using two predefined scar scales.

  • Other wound complications after caesarean section [ Time Frame: Within the first 30 days after Caesarean Section ]
    wound separation, wound exudate


Enrollment: 876
Study Start Date: September 10, 2013
Study Completion Date: December 2016
Primary Completion Date: October 13, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: iNPWT
Negative Pressure Wound Therapy (NPWT) is a mechanical wound care treatment using controlled sub-atmospheric pressure to assist and accelerate wound healing. Incisional Negative Pressure Wound Therapy (iNPWT) is a new NPWT devices, which can be used over clean closed surgical incisions. The device behaves in a similar fashion to existing conventional NPWT devices, i.e. transmission of negative pressure levels at the wound bed, tissue contraction and establishing a characteristic pattern of peri-wound blood flow and that it reduces and normalises tissue stresses at the incision
Device: iNPWT
The Incisional Negative Pressure Wound Therapy (iNPWT) will be applied over the clean closed incision immediately following the operation (caesarean section). In the intervention group the therapy will be left in situ for five days.
Other Name: incisional Negative Pressure Wound Therapy
Active Comparator: Standard wound dressing
The standard postoperative wound dressing is a normal wound dressing, used over clean closed incisions.
Other: Standard postoperative wound dressing
A standard wound dressing will be applied over the clean closed incision immediately following the operation (caesarean section). In the control group the dressing will be left in situ for at least 24 hours as standard procedure.

Detailed Description:

This study is a non-blinded randomised controlled trial and a concurrent Health Economic Evaluation. The study examines the effect on wound healing using incisional Negative Pressure Wound Therapy (iNPWT) compared with standard postoperative dressings in women with a BMI >= 30, who has a Caesarean Section (CS). We expect to find a lower frequency of wound complications when using iNPWT directly on primary suturing compared to standard postoperative dressings in this high-risk subpopulation.

Women, who have given informed consent, will be randomised to either intervention or control group via a computer-generated randomisation program. Elective and emergency CS will be stratified to ensure roughly equal numbers in each category of CS in each arm of the study and permit valid separate and pooled analysis. The analysis will be carried out on an intention to treat basis.

The iNPWT or standard postoperative dressings will be applied in theatre immediately following the operation. In the intervention group the therapy will be left in situ for five days corresponding to the date of removal of stitches. In the control group the dressing will be left in situ for at least 24 hours as standard procedure. Women, who do not wish to participate, will be asked for permission to use their data in the analysis.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 year
  • Women who can read and understand Danish
  • pregestational BMI ≥ 30 kg/m2

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01890720


Locations
Denmark
Aarhus University Hospital
Aarhus, Jutland, Denmark, 8200
Hospital South West Jutland
Esbjerg, Jutland, Denmark, 6700
Hospital Lillebaelt, Kolding Hospital
Kolding, Jutland, Denmark, 6000
Hvidovre Hospital
Hvidovre, Denmark, 2650
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Region of Southern Denmark
University of Southern Denmark
Hvidovre University Hospital
Smith & Nephew, Inc.
Investigators
Study Chair: Nana Hyldig, PhD Student Odense University Hospital, department of Plastic Surgery, University of Southern Denmark, Faculty of Health Sciences, institute of Clinical Research, research unit, department of Gynaecology and Obstetrics
  More Information

Additional Information:
Responsible Party: Nana Hyldig, PhD Student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01890720     History of Changes
Other Study ID Numbers: S-20130010
First Submitted: June 27, 2013
First Posted: July 2, 2013
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nana Hyldig, Odense University Hospital:
Randomized Controlled Trial
Economical Evaluation
Caesarean Section
postoperative wound treatment
surgical site infections
wound infections
infectious morbidity
Negative Pressure Wound Therapy
Incisional Negative Pressure Wound Therapy
Obesity

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wounds and Injuries
Rupture
Wound Infection
Surgical Wound
Surgical Wound Infection
Postoperative Complications
Pathologic Processes