SEROMA REDUCTION IN MASTECTOMY SAM Trial

SEROMA REDUCTION IN MASTECTOMY SAM Trial - SAM Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40829

Enrollment

336

Registered

2014-06-02

Start date

2014-06-12

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

fluid collection Seroma formation

Interventions

1. Mastectomy with closed suction drainage and skin closure 2. Mastectomy with flap fixation using absorbable sutures and closed suction drainage 3. Mastectomy with flap fixation using ARTISS tissue

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 Unable to comprehend implications and extent of study and sign for informed consent

Design outcomes

Primary

Measure	Time frame
Primary outcome: 1. Number of seroma aspirations	—

Secondary

Measure	Time frame
Secondary outcome: 1. Number of out patient clinic visits 2. Infection 3. Shoulder function 4. Cosmesis	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)