NCT07512141

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sindh Institute of Urology and Transplantation · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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).

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

Conditions

• Seroma Following Procedure
• Infections
• Pain, Postoperative

Interventions

Type	Name	Description
PROCEDURE	Double drains will be placed	In group A double drains will be placed, one in pectoral region and the other in axillary region.
PROCEDURE	A single drain will be placed	A single drain will be placed in axillary region.

Timeline

• Start date: 2026-03-27
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2026-04-06
• Last updated: 2026-04-06

Locations

1 site across 1 country: Pakistan