Trial Outcomes & Findings for Single Versus Double Drains After Mastectomy (NCT NCT02202252)

Results Overview

Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains. 1 denotes no discomfort related to drains, 10 denotes maximum discomfort unrelieved even with nonsteroid antiinflammatory analgesics. The data will be presented by median value and range (minimum-maximum).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Postoperative 5 days

Results posted on

2015-04-10

Participant Flow

The recruitment period: July 2014-february 2015 Location: Dıskapi Research and training Hospital General Surgery Clinic

Participant milestones

Participant milestones
Measure	Single Drain Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group. Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography. Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla. Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.	Double Drain Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group. Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography. Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group. Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single Versus Double Drains After Mastectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Drain n=30 Participants Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group. Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography. Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla. Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.	Double Drain n=30 Participants Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group. Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography. Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group. Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.	Total n=60 Participants Total of all reporting groups
Age, Continuous	54.1 years STANDARD_DEVIATION 11.6 • n=5 Participants	53.9 years STANDARD_DEVIATION 11.5 • n=7 Participants	54 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Postoperative 5 days

Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains. 1 denotes no discomfort related to drains, 10 denotes maximum discomfort unrelieved even with nonsteroid antiinflammatory analgesics. The data will be presented by median value and range (minimum-maximum).

Outcome measures

Outcome measures
Measure	Single Drain n=30 Participants Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group. Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography. Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla. Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.	Double Drain n=30 Participants Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group. Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography. Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group. Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.
Patient Comfort Scale	3 units on a scale Interval 1.0 to 8.0	3 units on a scale Interval 1.0 to 9.0

SECONDARY outcome

Timeframe: Twenty-four hours after removal of the drains up to 4 weeks

Seroma is defined as fluid accumulation below the flaps and will be examined daily after the operation. One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography..

Outcome measures

Outcome measures
Measure	Single Drain n=30 Participants Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group. Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography. Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla. Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.	Double Drain n=30 Participants Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group. Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography. Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group. Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.
Seroma Formation	18 participants	10 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 5 days

Outcome measures

Outcome measures
Measure	Single Drain n=30 Participants Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group. Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography. Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla. Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.	Double Drain n=30 Participants Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group. Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography. Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group. Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.
Length of Hospital Stay	3 days Interval 2.0 to 7.0	3 days Interval 2.0 to 17.0

Adverse Events

Single Drain

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Double Drain

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Melih Akinci, MD, Associate Prof

Diskapi Training and Research Hospital

Phone: 90 312 5962080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place