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

March 30, 2026 updated by: Bushra shirazi, Sindh Institute of Urology and Transplantation

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74200
        • Recruiting
        • Sindh Institute of Urology and Transplantation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (Double Drain)
In group A double drains will be placed, one in pectoral region and the other in axillary region.
Procedure: Double drains will be placed
In group A double drains will be placed, one in pectoral region and the other in axillary region.
Experimental: Group B (Single Drain)
while in group B, a single drain will be placed in axillary region; a 20 Fr JP drain would be used in both the groups
Procedure: A single drain will be placed
A single drain will be placed in axillary region.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroma Formation
Time Frame: Post-operative day 1 to day 30
Collection of fluid at the surgical bed, under the skin, confirmed by ultrasonography
Post-operative day 1 to day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Post-operative day 1 to day 30
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
Post-operative day 1 to day 30
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
Post-operative day 1 to day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sindh Institute of Urology and Transplantation

Investigators

  • Principal Investigator: Bushra Shirazi, FCPS, Sindh Institute of Urology and Transplantation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIUT-ERC-2025/A-577

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only the findings/outcomes of the study will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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