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Seroma Reduction After Mastectomy

NCT03305757 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 339

Last updated 2019-12-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Artiss

Application of ARTISS Glue to skin flaps after mastectomy

PROCEDURE

vicryl sutures

Flap fixation with vicryl sutures after mastectomy

PROCEDURE

Conventional

Conventional closure after mastectomy

Sponsors & Collaborators

  • Zuyderland Medisch Centrum

    lead OTHER

Principal Investigators

  • James van Bastelaar, MD · Zuyderland Medisch Centrum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-01
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03305757 on ClinicalTrials.gov