Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section
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|ClinicalTrials.gov Identifier: NCT01890720|
Recruitment Status : Completed
First Posted : July 2, 2013
Last Update Posted : January 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Surgical Wound Infection Infection; Cesarean Section Cesarean Section; Dehiscence Complications; Cesarean Section Complications; Cesarean Section, Wound, Dehiscence Wound; Rupture, Surgery, Cesarean Section||Device: iNPWT Other: Standard postoperative wound dressing||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||876 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Use of Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section in Women With BMI >=30|
|Study Start Date :||September 10, 2013|
|Actual Primary Completion Date :||October 13, 2016|
|Actual Study Completion Date :||December 2016|
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
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 Name: incisional Negative Pressure Wound Therapy
Active Comparator: Standard wound dressing
The standard postoperative wound dressing is a normal wound dressing, used over clean closed incisions.
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.
- The incidence of post-CS wound infection in each study group [ Time Frame: Within the first 30 days after surgery ]
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
- Length of the primary and any secondary hospitalization [ Time Frame: Within the first 30 days after Caesarean Section ]Primary for the health economic evaluation
- 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 ]Primary for the health economic evaluation
- 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 ]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
- Antibiotic treatment on suspicion of infection after Caesarean Section [ Time Frame: Within the first 30 days after Caesarean Section ]Primary for the health economic evaluation
- The cosmetic outcome as a measure of satisfaction [ Time Frame: A 6 and 12 months follow-up ]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.
- Other wound complications after caesarean section [ Time Frame: Within the first 30 days after Caesarean Section ]wound separation, wound exudate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01890720
|Aarhus University Hospital|
|Aarhus, Jutland, Denmark, 8200|
|Hospital South West Jutland|
|Esbjerg, Jutland, Denmark, 6700|
|Hospital Lillebaelt, Kolding Hospital|
|Kolding, Jutland, Denmark, 6000|
|Hvidovre, Denmark, 2650|
|Odense University Hospital|
|Odense, Denmark, 5000|
|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|