Overview

This trial is active, not recruiting.

Conditions surgical wound infection, infection; cesarean section, cesarean section; dehiscence, complications; cesarean section, complications; cesarean section, wound, dehiscence, wound; rupture, surgery, cesarean section
Treatments inpwt, standard postoperative wound dressing
Sponsor Odense University Hospital
Collaborator Region of Southern Denmark
Start date September 2013
End date November 2016
Trial size 870 participants
Trial identifier NCT01890720, S-20130010

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
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
inpwt incisional Negative Pressure Wound Therapy
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.
(Active Comparator)
The standard postoperative wound dressing is a normal wound dressing, used over clean closed incisions.
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.

Primary Outcomes

Measure
The incidence of post-CS wound infection in each study group
time frame: Within the first 30 days after surgery

Secondary Outcomes

Measure
Length of the primary and any secondary hospitalization
time frame: Within the first 30 days after Caesarean Section
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
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
Antibiotic treatment on suspicion of infection after Caesarean Section
time frame: Within the first 30 days after Caesarean Section
The cosmetic outcome as a measure of satisfaction
time frame: A 6 and 12 months follow-up
Other wound complications after caesarean section
time frame: Within the first 30 days after Caesarean Section

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Age ≥ 18 year - Women who can read and understand Danish - pregestational BMI ≥ 30 kg/m2 Exclusion Criteria:

Additional Information

Official title Use of Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section in Women With BMI >=30
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Odense University Hospital.