The effect of AVELLE negative pressure wound therapy in reducing postoperative wound complications in patients undergoing mastectomy and flap fiXation : a validation study

The effect of AVELLE negative pressure wound therapy in reducing postoperative wound complications in patients undergoing mastectomy and flap fiXation : a validation study - The ALEX validation study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48453

Enrollment

Registered

2019-04-17

Start date

2019-06-03

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

surgical site infection wound dehiscence wound necrosis

Interventions

Application of Avelle negative pressure wound therapy after standard mastectomy with flap fixation and closed suction drainage.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Older than 18 years female sex Indication for mastectomy or modified radical mastectomy

Exclusion criteria

Exclusion criteria: Patients undergoing breast conserving therapy. Patients undergoing direct breast reconstruction. Patients unable to comprehend implications and extent of study and sign for informed consent.

Design outcomes

Primary

Measure	Time frame
Patients with postoperative wound complications during the first three postoperative months.	—

Secondary

Measure	Time frame
1. Unplanned visits to the ER or breast cancer clinic. 2. Clinically significant seroma. See protocol for further explanation.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)