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The effectiveness of negative pressure wound therapy - PICO™ in the reduction of seroma formation following unilateral mastectomy, a case control study.

The effectiveness of negative pressure wound therapy in breast surgery patients compared to standard surgical dressing in the prevention of seroma formation following unilateral mastectomy.

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000598583
Acronym
PICO mastectomy study.
Enrollment
100
Registered
2015-06-09
Start date
2015-07-01
Completion date
2016-05-01
Last updated
2026-03-30

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

Conditions

None listed

Brief summary

Background Postoperative delayed wound healing impacts on patient wellbeing and return to normal life and can result in intrinsic and extrinsic complications. Unilateral mastectomy impacts on patient healing as well as body image perspective and is further complicated by the diagnosis of cancer. Aim of the study The purpose of the study is to determine the effectiveness of negative pressure wound therapy on seroma formation following unilateral mastectomy. Who is it for? The study is for females about to undergo an elective unilateral mastectomy that consent to be in the study. Study participants are randomly allocated (by chance) to one of two groups. Participants in one group will receive a negative pressure dressing applied to their wound for 7 days, whilst participants in the other group will receive a standard surgical dressing. Patients will be followed-up for up to 30 days postoperatively to determine seroma formation during the post operative period.

Interventions

Intervention is a negative pressure wound care dressing (NPWT). Intervention is administered by the surgeon and remains in place for 7 days. One dressing change on Day 5 or as close to as determined by level of strikethrough. This dressing delivers negative pressure to the wound bed to secure the flap and facilitate tissue perfusion.

Sponsors

St John of God Hosptial
Lead SponsorHospital

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 90 Years
Healthy volunteers
No

Inclusion criteria

Consenting females who are to undergo an elective unilateral mastectomy.

Exclusion criteria

Males Non consenting patients Females under 18 years of age

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 4, 2026