An interventional study of No drain and With drain in Breast Cancer, Seroma and Wound Complication, sponsored by Zuyderland Medisch Centrum. Recruiting at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-07.
Sponsored by Zuyderland Medisch Centrum · Not applicable, Interventional, and Treatment
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.
Rationale:
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.
The investigators hypothesize that flap fixation with closed suction drainage does not cause a significant lower incidence of seroma aspirations, when compared to flap fixation alone. The investigators also expect that patients without drainage will experience significantly less discomfort and comparable rates of surgical site infections.
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
Study population: Female patients > 18 years diagnosed with invasive breast cancer or DCIS (ductal carcinoma in situ) with an indication to perform mastectomy
Intervention (if applicable):
Main study parameters/endpoints:
Patients undergoing seroma aspiration (clinically significant seroma (CSS)).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 250 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Zuyderland Medisch Centrum is the lead sponsor of 64 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo mastectomy with flap fixation and low vacuum drainage.
Procedure: With drain
Patients undergo mastectomy with flap fixation and low vacuum drainage is omitted.
Procedure: No drain
Mastectomy with flap fixation without low vacuum drainage
Mastectomy with flap fixation with low vacuum drainage
Seroma aspiration of clinically significant seroma
Proportion of patients undergoing seroma aspiration of clinically significant seroma Clinically significant seroma defined as: 1. Wound healing is at risk due to seroma (wound break down, seroma leakage, necrosis) 2. There is discomfort or pain caused by large amounts of seroma, characterised by tenseness of the skin. 3. There is contaminated/ infected seroma and aspiration is necessary to treat infection. All patients that undergo seroma aspiration due to infection will also be treated with a one week course of Augmentin 625 mg 3 times daily.
Time frame: During first six months post-operative
Number of invasive interventions related to seroma or wound healing
Number of invasive interventions related to seroma or wound healing defined as: every aspiration of clinically significant seroma, incision and drainage of abscess or infected seroma and/or operative debriding of the wound.
Time frame: During first six months post-operative
Surgical site infection (SSI) rate
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.
Time frame: During the first six postoperative months
Cosmesis
Cosmesis rated by the patient using the numeric rating scale (NRS) every planned outpatient clinic visit.
Time frame: During the first six postoperative months
Quality of life measured using the SF-12 Health Survey
Quality of life measured using the SF-12 Health Survey. Resulting in 2 scores: the Mental Component Summary (MCS) and the Physical Component Summary (PCS). Both range between values of 0-100 with a score of 50 representing values of a standard population
Time frame: During the first six postoperative months
The number of outpatient department visits
The number of outpatient department visits
Time frame: During the first six months postoperative.
Experienced pain: NRS
Experienced wound pain and pain at the drain site by the patient using the NRS with a scale range from 0-10
Time frame: During the first six months postoperative
Plan to share: No
Started Jun 2020 (actual). Primary completion is estimated for Dec 2023, 42 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 42 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
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Zuyderland Medisch Centrum