Seroma Reduction After Mastectomy

• Status: Completed
• Trial end date: 2019-08-31
• Target enrollment: 0
• Participant gender: Female

Summary

Rationale: Seroma formation and its sequelae form the mainstay of complications in breast cancer surgery. Seroma has an incidence of 3% to 85%. Complications vary from delayed wound healing, infection, skin flap necrosis, patient discomfort and repeated visits to the out patient clinic. The key to reducing seroma formations seems to partly lie in the obliteration of dead space. The use of electrocautery has been demonstrated to increase seroma formation following mastectomy, however no other surgical devices (laser scalpel, argon diathermy and ultrasonic scalpel) or substances have proven to be superior in seroma reduction.

No prospective randomized controlled trials have been able to demonstrate which techniques are superior in reducing seroma and as a consequence patient discomfort in patients undergoing mastectomy. In a previous retrospective observational study these investigators demonstrated that mastectomy flap fixation significantly reduced seroma formation and the number of seroma aspirations. In a pilot study that was recently performed in one of the investigators hospitals, ARTISS tissue glue was used for skin flap fixation and showed promising results. The investigators hypothesize that obliteration of the dead space following mastectomy will significantly reduce seroma formation, its complications and the discomfort it causes patients undergoing mastectomy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zuyderland Medisch Centrum

Criteria

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

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