Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07512141

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

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Seroma Following Procedure Infections Inflammation Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Seroma Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sindh Institute of Urology and Transplantation

Karachi, Sindh, 74200, Pakistan

Location status: Recruiting

Location contact

Syed M Abbas, FCPS

CONTACT

[email protected]

+923331318838

About this study

All surgeries in this study will be performed by a consultant surgeon with at least 2 years of experience in breast surgery. This ensures uniformity and minimizes variation in outcomes related to surgical expertise Patients undergoing MRM will be divided into two groups, A & B. Flap quilting (skin flaps are sutured to the pectoralis muscle in interrupted fashion) will be done in both the groups using a Vicryl 2/0 suture, & skin will be closed using skin staplers.

Participants will be randomly assigned to one of the two study groups (Group A or Group B) using computer-based randomisation software. This ensures that the allocation is unbiased and purely by chance.

In group A double drains will be placed, one in pectoral region and the other in axillary region, while in group B single drain will be placed in axillary region; a 20 Fr JP drain would be used in both the groups Participants will be informed about the study's purpose, confidentiality will be ensured, and written informed consent will be obtained in the language of their preference (English/Urdu).

Observation will be made on the seroma formation, drain outputs, duration of drain placement & pain using the Visual Analogue Score (VAS) & incidence of surgical site infection.

The patient would be followed for drain output from postoperative day 1 to 30 (depending upon the removal of the drain), POD 7 & POD 14 and the subsequent next follow-up, & the patients will be assessed for seroma formation & surgical site infection & pain score. Seroma formation will be detected on clinical evaluation & will be confirmed on ultrasound imaging.

Patients who have received neoadjuvant therapy may have a higher risk of skin- and soft-tissue-related complications such as delayed wound healing, infection, or seroma formation. This factor will be considered in the analysis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Mastectomy & sentinel lymph node biopsy
  • Breast reconstruction surgery
  • Defect covering flaps

Treatment and study plan

Double drains will be placed

Procedure

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

A single drain will be placed in axillary region.

Primary outcomes

  1. Seroma Formation

    Time frame: Post-operative day 1 to day 30

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

Secondary outcomes

  1. Infection

    Time frame: Post-operative day 1 to day 30

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

  2. Duration of drains

    Time frame: Post-operative day 1 to day 30

    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

  3. Post-operative pain

    Time frame: Post-operative day 1 to day 30

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Bushra Shirazi, FCPS

CONTACT

[email protected]

+923009294840

Syed Abbas, FCPS

CONTACT

[email protected]

+923331318838

Sponsors and collaborators

Lead sponsor

Sindh Institute of Urology and Transplantation

Other

Registry information

Official study title

Comparative Analysis of Quilting Sutures With a Single Axillary Drain Versus Double Drains in the Axillary and Pectoral Regions for the Prevention of Seroma After Modified Radical Mastectomy

Acronym: SVDD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.