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

Not Applicable

Completed

• Conditions: Surgical Wound Infection; Cesarean Section; Dehiscence; Complications; Cesarean Section, Wound, Dehiscence; Infection; Cesarean Section; Complications; Cesarean Section; Wound; Rupture, Surgery, Cesarean Section
• Interventions: Device: iNPWT; Other: Standard postoperative wound dressing

• Registration Number: NCT01890720
• Lead Sponsor: Odense University Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2013-06-27
• Study First Submitted QC: 2013-07-01
• Study First Posted: 2013-07-02
• Study Start: 2013-09-10
• Primary Completion: 2016-10-13
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 876

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iNPWT	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
Standard wound dressing	Standard postoperative wound dressing	The standard postoperative wound dressing is a normal wound dressing, used over clean closed incisions.

Primary Outcome Measures

Name	Time	Method
The incidence of post-CS wound infection in each study group	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

Name	Time	Method
Length of the primary and any secondary hospitalization	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	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	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	Within the first 30 days after Caesarean Section	Primary for the health economic evaluation
The cosmetic outcome as a measure of satisfaction	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	Within the first 30 days after Caesarean Section	wound separation, wound exudate

Trial Locations

Locations (5)

Hospital South West Jutland; 🇩🇰 Esbjerg, Jutland, Denmark

Hospital Lillebaelt, Kolding Hospital; 🇩🇰 Kolding, Jutland, Denmark

Aarhus University Hospital; 🇩🇰 Aarhus, Jutland, Denmark

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark