Cesarean Section; Dehiscence, Complications; Cesarean Section, Complications; Cesarean Section, Wound, Dehiscence, Infection; Cesarean Section, Surgical Wound Infection, Wound; Rupture, Surgery, Cesarean Section
Conditions
Keywords
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
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.
Interventions
DEVICEiNPWT
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.
OTHERStandard 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.
Sponsors
Region of Southern Denmark
University of Southern Denmark
Hvidovre University Hospital
Smith & Nephew, Inc.
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 year * Women who can read and understand Danish * pregestational BMI ≥ 30 kg/m2
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Length of the primary and any secondary hospitalization | 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 |
| Antibiotic treatment on suspicion of infection after Caesarean Section | Within the first 30 days after Caesarean Section | Primary for the health economic evaluation |
Countries
Denmark
Outcome results
None listed