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

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cesarean Section; Dehiscence
• Communicable Diseases
• Complications; Cesarean Section
• Complications; Cesarean Section, Wound, Dehiscence
• Infection
• Infection; Cesarean Section
• Rupture
• Surgical Wound Infection
• Wound Infection
• Wound; Rupture, Surgery, Cesarean Section
• Wounds and Injuries

• NCT number: NCT01890720
• Study type: Interventional
• Source: Odense University Hospital
• Status: Completed
• Phase: N/A
• Start date: September 10, 2013
• Completion date: December 2016