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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgical Wound Infection, Infection; Cesarean Section, Cesarean Section; Dehiscence, Complications; Cesarean Section, Complications; Cesarean Section, Wound, Dehiscence, Wound; Rupture, Surgery, Cesarean Section

Intervention / Treatment
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* Device: iNPWT
* Other: Standard postoperative wound dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 year Women who can read and understand Danish pregestational BMI ≥ 30 kg/m2 Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iNPWT<br>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<br>* 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.<br>* Other names: incisional Negative Pressure Wound Therapy;|
| Active Comparator: Standard wound dressing<br>The standard postoperative wound dressing is a normal wound dressing, used over clean closed incisions. | Other: Standard postoperative wound dressing<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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