An interventional study of Double drains will be placed and A single drain will be placed in Seroma Following Procedure, Infections and Pain, Postoperative, sponsored by Sindh Institute of Urology and Transplantation. Recruiting at 1 site in Pakistan. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Sindh Institute of Urology and Transplantation · Not applicable, Interventional, and Prevention
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:
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
2,093 studies on the registry are indexed under Infections; 364 are open to participants now.
This study's planned enrollment of 60 is below the median of 113 across 1,304 interventional studies indexed under Infections.
Browse Infections studies →Sindh Institute of Urology and Transplantation is the lead sponsor of 18 studies on the registry; 6 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In group A double drains will be placed, one in pectoral region and the other in axillary region.
Procedure: Double drains will be placed
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
In group A double drains will be placed, one in pectoral region and the other in axillary region.
A single drain will be placed in axillary region.
Seroma Formation
Collection of fluid at the surgical bed, under the skin, confirmed by ultrasonography
Time frame: Post-operative day 1 to day 30
Infection
any signs of infection e.g., Temperature, redness of the skin around incision site, increased total leukocyte count
Time frame: Post-operative day 1 to day 30
Duration of drains
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
Time frame: Post-operative day 1 to day 30
Post-operative pain
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
Time frame: Post-operative day 1 to day 30
Plan to share: No — Only the findings/outcomes of the study will be shared
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sindh Institute of Urology and Transplantation