Seroma reduction and drain free mastectomy - SARA trial

Seroma reduction and drain free mastectomy - SARA trial - SARA

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48302

Enrollment

250

Registered

2019-03-20

Start date

2020-06-25

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fluid collection seroma formation

Interventions

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 clo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Older than 18 years - Female sex - Indication for mastectomy or modified radical mastectomy

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
Patients undergoing seroma aspiration (clinically significant seroma (CSS)).	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)