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Adding negative pRESSure to improve healING (the DRESSING trial)

Negative pressure wound therapy versus standard care dressing to prevent surgical site infections in obese women undergoing caesarean section.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000286549
Acronym
The DRESSING Trial (RCT)
Enrollment
2109
Registered
2015-03-26
Start date
2015-10-26
Completion date
2019-10-31
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 tube which is 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 infection, 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 care). 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 80mmHg 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 occurs the dressing

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 80mmHg 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 occurs 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 Resaerch Excellence in Nursing Interventions for Hospitalised Patients, Griffith University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Healthy volunteers
No

Inclusion criteria

1. Recorded body mass index (BMI) of equal to or greater than 30kg/m2 at the first antenatal booking visit. 2. Booked for elective caesarean section. 3. Semi-urgent caesarean section (as per treating Specialist).

Exclusion criteria

1. Previous participation in the trial. 2. Being treated for an existing infection with antibiotics after admission and prior to caesarean section. 3. Non-English speaking patients without an interpreter. 4. Clinical suspicion of chorioamnionitis.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 2, 2026