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ANNIE

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-OMON58599
Enrollment
352
Registered
2026-01-30
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-05-18

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

Conditions

Clinical significant seroma, seroma, surgical site infection, bleeding complications Fluid collection after surgery, wound infection, bleeding after surgery

Interventions

The intervention consists of fixing the skin flaps to the chest muscle using stitches. One group receives running stitches, where the stitch runs continuously, and the other group receives interrupted

Sponsors

Zuyderland
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:Female sex.18 years or older.Indication for mastectomy. 

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:Patients undergoing breast conserving therapyPatients undergoing direct breast reconstruction Patients undergoing modified radical mastectomyUnable to comprehend implications and extent of study and sign for informed consent

Design outcomes

Primary

MeasureTime frame
The main outcome of this study is the number of patients who develop complications that require treatment after surgery. These complications include fluid buildup under the skin, wound infection, or bleeding after surgery.

Secondary

MeasureTime frame
Secondary outcomes include the length of the surgery and how satisfied patients are with the cosmetic result after the operation.

Countries

Netherlands

Contacts

Public ContactK.S.F. Willems

Zuyderland

kay.willems@zuyderland.nl0884597777

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 22, 2026