Clinical trial NCT01890720: Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section
Official title: Use of Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section in Women With BMI >=30
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Infection
Infection; Cesarean Section
Cesarean Section; Dehiscence
Complications; Cesarean Section
Complications; Cesarean Section, Wound, Dehiscence
Wound; Rupture, Surgery, Cesarean Section
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
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
name: University of Southern Denmark
name: Hvidovre University Hospital
name: Smith & Nephew, Inc.
First posted: 2013-07-02
Enrollment: 876
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 year
* Women who can read and understand Danish
* pregestational BMI ≥ 30 kg/m2

Exclusion Criteria:

-

Primary outcomes:
measure: The incidence of post-CS wound infection in each study group
timeFrame: Within the first 30 days after surgery
Secondary outcomes:
measure: Length of the primary and any secondary hospitalization
timeFrame: Within the first 30 days after Caesarean Section
measure: Readmissions to hospital/contact to the general practitioner on suspicion of infection following caesarean section
timeFrame: Within the first 30 days after Caesarean Section
measure: Number of Participants with a decreased health-related quality of life score as a measure of satisfaction and tolerability
timeFrame: Within the first 30 days after Caesarean Section
measure: Antibiotic treatment on suspicion of infection after Caesarean Section
timeFrame: Within the first 30 days after Caesarean Section
measure: The cosmetic outcome as a measure of satisfaction
timeFrame: A 6 and 12 months follow-up
measure: Other wound complications after caesarean section
timeFrame: Within the first 30 days after Caesarean Section
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Jutland
city: Esbjerg
country: Denmark
facility: Hospital South West Jutland
state: Jutland
city: Kolding
country: Denmark
facility: Hospital Lillebaelt, Kolding Hospital
state: Jutland
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital, department of Plastic Surgery, University of Southern Denmark, Faculty of Health Sciences, institute of Clinical Research, research unit, department of Gynaecology and Obstetrics
name: Nana Hyldig, PhD Student
role: STUDY_CHAIR
References: