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Testing the effectiveness of negative pressure wound therapy in the at risk obstetric population for the prevention of surgical wound complications: The CYGNUS Trial.

EffiCacY of neGative pressure wound therapy in the preventioN of surgical woUnd complicationS in the cesarean section at risk population: a randomised multi-centre trial, the CYGNUS trial.

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618002006224
Acronym
CYGNUS
Enrollment
449
Registered
2018-12-13
Start date
2019-01-07
Completion date
Unknown
Last updated
2024-10-07

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

Conditions

None listed

Brief summary

This study will determine the efficacy of advanced negative pressure wound therapy compared to a standard dressing protocol in the prevention if surgical wound breakdown following c-section delivery. The benefit of the study is to prevent this complication and improve the health and well-being of the mother following c-section delivery.

Interventions

Negative pressure wound therapy (NPWT) applied over the surgical incision (C-section) is an advanced wound dressing. The NPWT device consists of a single patient use battery operated pump attached to a sterile dressing. A nominal negative pressure of 80mmHg is maintained at the wound surface through the dressing delivered by the pump. The control dressing does not deliver negative pressure therapy and is a sterile dressing covering the incision site. The surgeon/assisting surgeon/wound care c

Negative pressure wound therapy (NPWT) applied over the surgical incision (C-section) is an advanced wound dressing. The NPWT device consists of a single patient use battery operated pump attached to a sterile dressing. A nominal negative pressure of 80mmHg is maintained at the wound surface through the dressing delivered by the pump. The control dressing does not deliver negative pressure therapy and is a sterile dressing covering the incision site. The surgeon/assisting surgeon/wound care clinician will apply the dressing in theatre once the incision is closed and prepared for the dressing. The dressing (intervention or control) will be applied following the surgical procedure.The intervention will remain in place for 7 days.

Sponsors

University of Western Australia
Lead SponsorUniversity

Study design

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

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Pregnant Informed consent obtained

Exclusion criteria

Males Non consenting patients

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 17, 2026