Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section
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.
Surgical Wound Infection
Infection; Cesarean Section
Cesarean Section; Dehiscence
Complications; Cesarean Section
Complications; Cesarean Section, Wound, Dehiscence
Wound; Rupture, Surgery, Cesarean Section
Device: PICO from Smith&Nephew
Other: Standard postoperative wound dressing
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Use of Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section in Women With BMI >=30|
- The incidence of post-CS wound infection in each study group [ Time Frame: Within the first 30 days after surgery ] [ Designated as safety issue: No ]
All participants will have there incision assessed for signs of infections by an experienced infection control nurse five days postpartum.
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
- Length of the primary and any secondary hospitalization [ Time Frame: Within the first 30 days after Caesarean Section ] [ Designated as safety issue: No ]
- Readmissions to hospital/contact to the general practitioner on suspicion of infection following Caesarean Section [ Time Frame: Within the first 30 days after Caesarean Section ] [ Designated as safety issue: No ]
- Number of Participants with a decreased health-related quality of life score as a measure of satisfaction and tolerability [ Time Frame: Within the first 30 days after Caesarean Section ] [ Designated as safety issue: No ]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
- Antibiotic treatment on suspicion of infection after Caesarean Section [ Time Frame: Within the first 30 days after Caesarean Section ] [ Designated as safety issue: No ]
- The cosmetic outcome as a measure of satisfaction [ Time Frame: A 6 and 12 months follow-up ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Negative Pressure Wound Therapy (NPWT) is a mechanical wound care treatment using controlled sub-atmospheric pressure to assist and accelerate wound healing. Incisional Negative Pressure Wound Therapy (iNPWT) is a new NPWT devices, which can be used over clean closed surgical incisions. The device behaves in a similar fashion to existing conventional NPWT devices, i.e. transmission of negative pressure levels at the wound bed, tissue contraction and establishing a characteristic pattern of peri-wound blood flow and that it reduces and normalises tissue stresses at the incision
Device: PICO from Smith&Nephew
The Incisional Negative Pressure Wound Therapy (iNPWT) or standard postoperative dressings 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. In the control group the dressing will be left in situ for at least 24 hours as standard procedure.
Other Name: Incisional Negative Pressure Wound Therapy
Standard postoperative wound dressing
The standard postoperative wound dressing is a normal wound dressing, used over clean closed incisions.
|Other: Standard postoperative wound dressing|
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.
|Contact: Nana Hyldig, PhD Student||0045 firstname.lastname@example.org|
|Contact: Jan stener Joergensen, MD, PhD||0045 email@example.com|
|Hvidovre Hospital||Not yet recruiting|
|Hvidovre, Denmark, 2650|
|Contact: Tom Weber, MD 0045 40136306 firstname.lastname@example.org|
|Principal Investigator: Tom Weber, MD|
|Odense University Hospital||Recruiting|
|Odense, Denmark, 5000|
|Contact: Nana Hyldig, PhD Student 0045 65415156 email@example.com|
|Principal Investigator: Nana Hyldig, PhD Student|
|Study Chair:||Nana Hyldig, PhD Student||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|