Trial record 2 of 168 for:    Open Studies | "Cesarean Section"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Odense University Hospital
Sponsor:
Collaborators:
Region Southern Denmark
University of Southern Denmark
Hvidovre University Hospital
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Nana Hyldig, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01890720
First received: June 27, 2013
Last updated: February 26, 2014
Last verified: February 2014
  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: PICO from Smith&Nephew
Other: Standard postoperative wound dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 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 ] [ Designated as safety issue: No ]

    All participants will have there incision assessed for signs of infections by an experienced infection control nurse five days postpartum.

    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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

  • Antibiotic treatment on suspicion of infection after Caesarean Section [ Time Frame: Within the first 30 days after Caesarean Section ] [ Designated as safety issue: No ]
  • The cosmetic outcome as a measure of satisfaction [ Time Frame: A 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 948
Study Start Date: September 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2015 (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: PICO from Smith&Nephew

The Incisional Negative Pressure Wound Therapy (iNPWT) or standard postoperative dressings 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. In the control group the dressing will be left in situ for at least 24 hours as standard procedure.

Other Name: Incisional Negative Pressure Wound Therapy
Standard postoperative wound dressing
The standard postoperative wound dressing is a normal wound dressing, used over clean closed incisions.
Other: Standard postoperative wound dressing

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 year
  • Women who can read and understand Danish
  • BMI ≥ 30

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890720

Contacts
Contact: Nana Hyldig, PhD Student 0045 65415156 nana.hyldig@rsyd.dk
Contact: Jan stener Joergensen, MD, PhD 0045 65412346 jan.stener.joergensen@rsyd.dk

Locations
Denmark
Hospital South West Jutland Not yet recruiting
Esbjerg, Jutland, Denmark, 6700
Contact: Mette Ibsen, MD       mette.holm.ibsen@rsyd.dk   
Contact: Nana Hyldig, PhD student    65415156 ext 0045    nana.hyldig@rsyd.dk   
Sub-Investigator: Mette Ibsen, MD         
Hospital Lillebaelt, Kolding Hospital Not yet recruiting
Kolding, Jutland, Denmark, 6000
Contact: Lene Nyhoj, MD       lene.nyhoj@rsyd.dk   
Contact: Nana Hyldig, PhD student    65415156 ext 0045    nana.hyldig@rsyd.dk   
Sub-Investigator: Lene Nyhoj, MD         
Hvidovre Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Tom Weber, MD    0045 40136306    tom.weber@dadlnet.dk   
Principal Investigator: Tom Weber, MD         
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Nana Hyldig, PhD Student    0045 65415156    nana.hyldig@rsyd.dk   
Principal Investigator: Nana Hyldig, PhD Student         
Sponsors and Collaborators
Odense University Hospital
Region 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:
No publications provided

Responsible Party: Nana Hyldig, PhD Student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01890720     History of Changes
Other Study ID Numbers: S-20130010
Study First Received: June 27, 2013
Last Updated: February 26, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by 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:
Surgical Wound Infection
Wound Infection
Rupture
Infection
Postoperative Complications
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on July 24, 2014