NCT01890720

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 876 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2013-09-10
• Primary completion: 2016-10-13
• Completion: 2016-12-01
• First posted: 2013-07-02
• Last updated: 2017-01-31

Locations

5 sites across 1 country: Denmark