Surgical Wound Infection Clinical Trial
Official title:
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.
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.
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