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

Use of Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section in Women With BMI >=30

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.

Study Overview

• Status: Completed
• Conditions: Surgical Wound Infection; Cesarean Section; Dehiscence; Complications; Cesarean Section; Infection; Cesarean Section; Complications; Cesarean Section, Wound, Dehiscence; Wound; Rupture, Surgery, Cesarean Section
• Intervention / Treatment: Device: iNPWT; 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.

• Study Type: Interventional
• Enrollment (Actual): 876
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital
  • Odense, Denmark, 5000
    • Odense University Hospital
  • Jutland
    • Aarhus, Jutland, Denmark, 8200
      • Aarhus University Hospital
    • Esbjerg, Jutland, Denmark, 6700
      • Hospital South West Jutland
    • Kolding, Jutland, Denmark, 6000
      • Hospital Lillebaelt, Kolding Hospital

Participation Criteria

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of post-CS wound infection in each study group	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	Within the first 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of the primary and any secondary hospitalization	Primary for the health economic evaluation	Within the first 30 days after Caesarean Section
Readmissions to hospital/contact to the general practitioner on suspicion of infection following caesarean section	Primary for the health economic evaluation	Within the first 30 days after Caesarean Section
Number of Participants with a decreased health-related quality of life score as a measure of satisfaction and tolerability	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	Within the first 30 days after Caesarean Section
Antibiotic treatment on suspicion of infection after Caesarean Section	Primary for the health economic evaluation	Within the first 30 days after Caesarean Section
The cosmetic outcome as a measure of satisfaction	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.	A 6 and 12 months follow-up
Other wound complications after caesarean section	wound separation, wound exudate	Within the first 30 days after Caesarean Section

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Hvidovre University Hospital; Smith & Nephew, Inc.; University of Southern Denmark; Region of Southern Denmark

Study record dates

Study Major Dates

• Study Start: September 10, 2013
• Primary Completion (Actual): October 13, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: June 27, 2013
• First Submitted That Met QC Criteria: July 1, 2013
• First Posted (Estimate): July 2, 2013

Study Record Updates

• Last Update Posted (Estimate): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Obesity; Randomized Controlled Trial; surgical site infections; Caesarean Section; Negative Pressure Wound Therapy; Economical Evaluation; wound infections; postoperative wound treatment; infectious morbidity; Incisional Negative Pressure Wound Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Rupture; Surgical Wound; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: S-20130010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No