Breast Cancer Clinical Trial
— SARAOfficial title:
Seroma Reduction and Drain Free Mastectomy
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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Older than 18 years - Female sex - Indication for mastectomy Exclusion Criteria: - Patients undergoing breast conserving therapy - Patients undergoing modified radical mastectomy - Patients undergoing direct breast reconstruction - Unable to comprehend implications and extent of study and sign for informed consent - Patients with radiation therapy of unilateral breast in previous history |
Country | Name | City | State |
---|---|---|---|
Netherlands | Zuyderland Medisch Centrum | Sittard | Limburg |
Lead Sponsor | Collaborator |
---|---|
Zuyderland Medisch Centrum |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Seroma aspiration of clinically significant seroma | Proportion of patients undergoing seroma aspiration of clinically significant seroma
Clinically significant seroma defined as: Wound healing is at risk due to seroma (wound break down, seroma leakage, necrosis) There is discomfort or pain caused by large amounts of seroma, characterised by tenseness of the skin. 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. |
During first six months post-operative | |
Secondary | 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. | During first six months post-operative | |
Secondary | 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. | During the first six postoperative months | |
Secondary | Cosmesis | Cosmesis rated by the patient using the numeric rating scale (NRS) every planned outpatient clinic visit. | During the first six postoperative months | |
Secondary | 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 | During the first six postoperative months | |
Secondary | The number of outpatient department visits | The number of outpatient department visits | During the first six months postoperative. | |
Secondary | 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 | During the first six months postoperative |
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