To prove that omitting drains after mastectomy and flap fixation does not contribute to higher incidence of seroma formation and therefore reducing patient disutility such as seroma aspirations and visits to the outpatient clinic, as well as…
ID
Source
Brief title
Condition
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patients undergoing seroma aspiration (clinically significant seroma (CSS)).
Secondary outcome
To assess
1. Number of invasive interventions related to seroma or wound healing defined
as: every aspiration of clinically significant seroma, incision and drainage of
abscess or in-fected seroma and/or operative debriding of the wound.
2. Surgical site infection (SSI) rate, defined as redness, pain, heat or
swelling at the site of the incision or by the drainage of pus. Infection rate
will be measured by A) the need for antibiotics, B) seroma aspiration due to
infection or C) surgical drainage during the first six postoperative months.
3. Cosmesis rated by the patient using the numeric rating scale (NRS) every
planned outpatient clinic visit.
4. Quality of life measured using the SF-12 Health Survey
5. The number of outpatient department visits, measured during the first six
months postoperative.
6. Experienced wound pain and pain at the drain site by the patient using the
NRS.
Background summary
Seroma formation, a collection of serous fluid containing blood plasma and/or
lymph fluid, is a common complication in breast cancer surgery and can lead to
delayed wound healing, infection, skin flap necrosis, patient discomfort and
repeated visits to the outpatient clinic and therefore extensive research has
been done to further elucidate the pathophysiology and prevention of seroma
formation. Promising results have resulted from studies focusing on flap
fixation in order to reduce the incidence of seroma and seroma aspirations.
Mastectomy with flap fixation is becoming standard practice and is currently
combined with closed-suction drainage. Closed-suction drainage is considered
gold standard for reducing seroma formation after breast cancer surgery.
However, evidence shows that closed-suction drainage is insufficient in
preventing seroma formation. One might wonder if there is still a place for
closed-suction drainage after mastectomy if flap fixation is performed. The
promising results in flap fixation could exclude drainage systems in breast
cancer surgery. However, the available data consist of small case series and
therefore a large randomized controlled trial is needed for it to be widely
implemented.
To our knowledge, no randomized controlled trial has been conducted comparing
flap fixation with and without closed-suction drainage with seroma aspiration
as the primary outcome.
We hypothesize that flap fixation with closed suction drainage does not cause a
significant lower incidence of seroma aspirations, when compared to flap
fixation alone. We also expect that patients without drainage will experience
significantly less discomfort and comparable rates of surgical site infections.
Study objective
To prove that omitting drains after mastectomy and flap fixation does not
contribute to higher incidence of seroma formation and therefore reducing
patient disutility such as seroma aspirations and visits to the outpatient
clinic, as well as reducing seroma related wound complications.
Study design
Prospective randomized controlled trial
Intervention
1. Mastectomy with flap fixation using ARTISS tissue glue and mattress sutures
with closed suction drainage
2. Mastectomy with flap fixation using ARTISS tissue glue and mattress sutures
without closed suction drainage
Study burden and risks
Patients will be informed about the study before inclusion in the outpatient
clinic. Informed consent will be obtained in the outpatient clinic a week after
patients were initially informed. Postoperative check-ups will be done more
frequently. Standard postoperative check-ups are planned at 2 weeks and 3
months. Additional study postoperative check-ups: 6 weeks, 6 months. Therefore,
patients will be required to undergo two additional check-ups.
During out patients* visits, patients will hand in a questionnaire scale
regarding cosmesis, pain and quality of life.
Patients will be clinically examined as they usually would be.
Dr. H. van der Hoffplein 1
Sittard 6162 BG
NL
Dr. H. van der Hoffplein 1
Sittard 6162 BG
NL
Listed location countries
Age
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
- Patients undergoing modified radical mastectomy
- Unable to comprehend implications and extent of study and sign for informed
consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL68870.096.19 |