Fixation of skin flaps after mastectomy using running or interrupted sutures for combatting seroma

Fixation of skin flaps after mastectomy using running or interrupted sutures for combatting seroma - ANNIE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57699

Enrollment

361

Registered

2023-06-28

Start date

2025-01-01

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Breast cancer mamma carcinoma

Interventions

Group 1: Flap fixation after mastectomy with running sutures. Group 2: Flap fixation after mastectomy with interrupted sutures.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Female sex. - 18 years or older. - Indication for mastectomy.

Exclusion criteria

Exclusion criteria: - Patients undergoing breast conserving therapy - Patients undergoing direct breast reconstruction - Patients undergoing modified radical mastectomy - Unable to comprehend implications and extent of study and sign for informed consent

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the incidence of complications requiring interventions in both groups, including clinically significant seroma, infections and bleeding complications.	—

Secondary

Measure	Time frame
Secondarily, the length of the procedure and cosmetic results will be compared.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)