The role of PREVENA vacuum dressings in patients undergoing breast surgery affecting both sides

The role of PREVENA vacuum dressings in patients undergoing bilateral mammoplasty surgery

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN30055885

Enrollment

150

Registered

2020-08-13

Start date

2020-02-13

Completion date

Unknown

Last updated

2023-06-20

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

Conditions

Patients undergoing a mammoplasty procedure for cancer Surgery

Interventions

This is a single centre blinded study (wound assessing clinicians are blinded). Patients are randomised in a 1:1 fashion. All enrolled patients will be undergoing bilateral surgery and shall be inclu

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Patients undergoing bilateral Wise pattern or vertical scar mammoplasty surgery 2. Indication for surgery: unilateral oncoplastic procedure with simultaneous contralateral symmetrising surgery 3. English speaking 4. Capacity to consent 5. Age 18-80 years

Exclusion criteria

Exclusion criteria: 1. Sensitivity to silver (PREVENA is contraindicated)

Design outcomes

Primary

Measure	Time frame
The overall occurrence of surgical site complication (SSC) rate at 6 weeks. Patients who experience any of the following complications (infection, necrosis, wound dehiscence) will be counted as an occurrence.	—

Secondary

Measure	Time frame
Assessed clinically 1, 2 and 6 weeks unless otherwise stated: 1. Infection occurrence as binary outcome (yes/no) for each patient 2. Clinical assessment using the ASEPSIS scoring system 3. USS for all patients who have clinical signs of infection (as per validated score system) 4. If collection seen, USS guided aspiration, documenting volume and fluid type (1. Pus, 2. Seroma, 3. Fat necrosis) 5. Skin/nipple necrosis evaluated in the following ways: 5.1. Skin/nipple occurrence as binary outcome (yes/no) for each patient 5.2. Percentage of skin necrosis of the total wound length for each patient 5.3. Percentage of nipple necrosis of the total nipple area for each patient 6. Wound dehiscence occurrence as binary outcome (yes/no) for each patient 7. Pain measured using visual analogue scale (1-10) 8. Return to theatre (including laterality of problem leading to re-admission presentation) at 30 days 9. Re-admission rates (including laterality of problem leading to re-admission presentation) at 30 days	—

Measure

Time frame

Assessed clinically 1, 2 and 6 weeks unless otherwise stated: 1. Infection occurrence as binary outcome (yes/no) for each patient 2. Clinical assessment using the ASEPSIS scoring system 3. USS for all patients who have clinical signs of infection (as per validated score system) 4. If collection seen, USS guided aspiration, documenting volume and fluid type (1. Pus, 2. Seroma, 3. Fat necrosis) 5. Skin/nipple necrosis evaluated in the following ways: 5.1. Skin/nipple occurrence as binary outcome (yes/no) for each patient 5.2. Percentage of skin necrosis of the total wound length for each patient 5.3. Percentage of nipple necrosis of the total nipple area for each patient 6. Wound dehiscence occurrence as binary outcome (yes/no) for each patient 7. Pain measured using visual analogue scale (1-10) 8. Return to theatre (including laterality of problem leading to re-admission presentation) at 30 days 9. Re-admission rates (including laterality of problem leading to re-admission presentation) at 30 days

—

Countries

England, United Kingdom

Contacts

Public ContactLorna Ingoe

l.ingoe@nhs.net+44 (0)191 2139283

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026