None listed
Conditions
Brief summary
Obesity is a growing global public health problem in developed nations. It is estimated that half of all Australian women of childbearing age are overweight or obese. Obese pregnant women are more likely to deliver their babies by Caesarean Section and are also more likely to have complications such as Surgical Site Infections after Caesarean Section than non-obese women. Wounds that fail to heal may cause considerable distress to patients and negatively affect the physical, social, emotional and economic aspects of their life. Wound complications also add to the cost of health care. Negative Pressure Wound Therapy has been used to aid healing since it was first developed in the late 1990s. The treatment is based on a closed sealed system that produces negative pressure to the wound surface. The wound is covered and sealed with an occlusive dressing and suction tubes which are connected to a vacuum pump which provides intermittent or continuous suction. Negative Pressure Wound Therapy is being used more frequently as a way to prevent wound complications especially Surgical Site Infections, but it has not been well tested yet. This study will test the effectiveness of two different methods to dress surgical wounds following Caesarean Section. These include Negative Pressure Wound Therapy compared to current care (standard dressing). We are doing this research study to find out the best practice for preventing Surgical Site Infections in obese women. To do this, we need to study women with a Body Mass Index (BMI) greater than or equal to 30 for one month following their surgery, and closely monitor their surgical wound
Interventions
At the completion of skin closure, those women randomly allocated to the Negative Pressure Wound Therapy (NPWT) will have a PICO Trademark (Smith and Nephew) applied. The gauze based dressing will be secured over the incision with fixation strips and continuous negative pressure of 80mm Hg will be delivered via a tube embedded into the gauze by a small portable battery operated device. The dressing will remain in place for 4 days, unless it becomes soiled or dislodged. If this occurrs the dressi
At the completion of skin closure, those women randomly allocated to the Negative Pressure Wound Therapy (NPWT) will have a PICO Trademark (Smith and Nephew) applied. The gauze based dressing will be secured over the incision with fixation strips and continuous negative pressure of 80mm Hg will be delivered via a tube embedded into the gauze by a small portable battery operated device. The dressing will remain in place for 4 days, unless it becomes soiled or dislodged. If this occurrs the dressing will be changed using aseptic technique. All women (both intervention and control groups) will receive prophylactic antibiotics. All other aspects of their care will be consistent between the groups.
Sponsors
NHMRC Centre of Research Excellence in Nursing Interventions for Hospitalised Patients, Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
(i) informed written informed consent (ii) recorded Body Mass Index (BMI) of equal to or greater than 30kg/m2 at the first antenatal visit as per the Queensland Maternity and Neonatal Clinical Guideline 2010 (iii) booked for elective CS surgery (before the commencement of labour)
Exclusion criteria
(i) Non-English speaking patients without interpreter (ii) existing infection (iii) Previous participation in this trial
Outcome results
None listed