Single Versus Double Drains in the Axillary and Pectoral Regions After Modified Radical Mastectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorSindh Institute of Urology and Transplantation

About this trial

Normally, after this surgery, skin is stitched in the usual simple way, with no quilting, and two drains are put in to remove serosa, one under the arm and one on the chest. In this study, the investigator will use a different type of stitch called a quilting stitch, which helps stick the skin to the chest muscle so there is less serosa collection. The investigator will compare two groups:

* Group A: Quilting stitches with two drains (one under the arm and one on the chest). * Group B: Quilting stitches with one drain only (under the arm).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients older than 18 years but less than 70 years of age,

Diagnosed with breast carcinoma.

All the patients undergoing upfront MRM,

All patients undergoing MRM post-neoadjuvant chemotherapy.

Disqualifiers

Mastectomy & sentinel lymph node biopsy

Breast reconstruction surgery

Defect covering flaps

Trial design

Design model

Parallel

Treatments tested in this trial

  • Double drains will be placed

    Procedure/Surgery

    In group A double drains will be placed, one in pectoral region and the other in axillary region.

  • A single drain will be placed

    Procedure/Surgery

    A single drain will be placed in axillary region.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group A (Double Drain)Active comparator 1 intervention
Group B: Group B (Single Drain)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Seroma Formation

Collection of fluid at the surgical bed, under the skin, confirmed by ultrasonography

Time frame
Post-operative day 1 to day 30

Secondary outcomes

1

Infection

any signs of infection e.g., Temperature, redness of the skin around incision site, increased total leukocyte count

Time frame
Post-operative day 1 to day 30
2

Duration of drains

If there's no fluid or blood collecting in the drains and ultrasonography shows no collection at the surgical site under the skin, it shows the drains can be taken out

Time frame
Post-operative day 1 to day 30
3

Post-operative pain

The Visual Analogue Scale (VAS) is a validated, subjective, and continuous measurement tool for assessing pain intensity, discomfort, or severity. It consists of a 10-cm (100 mm) horizontal line, anchored by "no pain" and "worst imaginable pain". Patients mark the point representing their experience. Common Pain Intensity Classifications: 0-4 mm: No pain. 5-44 mm: Mild pain. 45-74 mm: Moderate pain. 75-100: Worst imaginable pain No pain \[------------------------------------------------\] Worst imaginable pain 0---1---2---3---4---5---6---7---8---9---10 Moderate Pain

Time frame
Post-operative day 1 to day 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.