Single versus double drains after modified radical mastectomy with quilting stitches
Official 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
Run by Sindh Institute of Urology and Transplantation · NCT07512141 · Data updated 2026-11-12
This trial will test whether using one drain instead of two, together with quilting stitches, reduces fluid buildup, pain, and infections after modified radical mastectomy for adults with breast cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | Sindh Institute of Urology and Transplantation Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Karachi, Sindh) |
| Status | Recruiting |
| Started | March 27, 2026 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | April 6, 2026 |
| Trial ID | NCT07512141 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–69 with diagnosed breast carcinoma who are scheduled for upfront or post-neoadjuvant modified radical mastectomy are the intended participants.
✕Probably not a fit
Patients having mastectomy with sentinel lymph node biopsy, immediate breast reconstruction, or flap coverage are excluded and would not be eligible to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients undergoing modified radical mastectomy will all receive flap quilting (suturing the skin flaps to the pectoralis muscle) and standard skin closure performed by experienced breast surgeons. Participants are randomly assigned to receive either two drains (pectoral and axillary) or a single axillary drain, with a 20 Fr JP drain used in both groups. Outcomes recorded include seroma formation, drain output and duration, pain by Visual Analogue Scale, and surgical site infection, with follow-up on postoperative days 1–30 and at routine clinic visits including day 7 and day 14. Informed consent is obtained in English or Urdu and allocation is done by computer-based randomisation to minimise bias.
Why it matters
Potential benefit: If successful, patients may experience less fluid collection, shorter drain times, less pain, and fewer wound infections after surgery.
How similar studies have gone: Previous research has shown that quilting stitches can reduce seroma formation, but direct comparisons of one versus two drains after quilting have been less commonly reported.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Sindh Institute of Urology and Transplantation
Karachi, Sindh, Pakistan Recruiting
Study contacts
- Principal investigator: Bushra Shirazi, FCPS — Sindh Institute of Urology and Transplantation
- Study coordinator: Syed Abbas, FCPS
- Email: smabbas69@hotmail.com
- Phone: +923331318838
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.