Single versus double drains after modified radical mastectomy with quilting stitches
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Sindh Institute of Urology and Transplantation Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT07512141 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Karachi, Sindh
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.