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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01890720
• Other study ID #: S-20130010
• Status: Completed
• Phase: N/A
• First received: June 27, 2013
• Last updated: January 30, 2017
• Start date: September 10, 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 876
• Est. completion date: December 2016
• Est. primary completion date: October 13, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 year

• Women who can read and understand Danish

• pregestational BMI = 30 kg/m2

Exclusion Criteria:

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

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Jutland
Denmark	Hospital South West Jutland	Esbjerg	Jutland
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Hospital Lillebaelt, Kolding Hospital	Kolding	Jutland
Denmark	Odense University Hospital	Odense

Sponsors (5)

Lead Sponsor	Collaborator
Odense University Hospital	Hvidovre University Hospital, Region of Southern Denmark, Smith & Nephew, Inc., University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of the primary and any secondary hospitalization	Primary for the health economic evaluation	Within the first 30 days after Caesarean Section
Secondary	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
Secondary	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
Secondary	Antibiotic treatment on suspicion of infection after Caesarean Section	Primary for the health economic evaluation	Within the first 30 days after Caesarean Section
Secondary	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
Secondary	Other wound complications after caesarean section	wound separation, wound exudate	Within the first 30 days after Caesarean Section

External Links

•   A website for use by the project participants