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

Completed

• Conditions: surgical site infection; wound dehiscence; wound necrosis; 10006295

• Registration Number: NL-OMON48453
• Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Patients with postoperative wound complications during the first three<br /><br>postoperative months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Unplanned visits to the ER or breast cancer clinic.<br /><br>2. Clinically significant seroma.<br /><br><br /><br>See protocol for further explanation. </p><br>