Seroma Following ProcedureSVDDNCT07512141
Single Versus Double Drains in the Axillary and Pectoral Regions After Modified Radical Mastectomy
A study testing Double drains will be placed and A single drain will be placed in people with Seroma Following Procedure and Infections, run by Sindh Institute of Urology and Transplantation at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Seroma Following Procedure, Infections, Pain, Postoperative
- What is being tested?
- Double drains will be placed and A single drain will be placed
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Mar 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Mastectomy \& sentinel lymph node biopsy
- Breast reconstruction surgery
- Defect covering flaps
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Sindh Institute of Urology and Transplantation
Karachi, Sindh, 74200
Syed M Abbas, FCPS, +923331318838, smabbas69@hotmail.com
About this study
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
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).
Read the 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
- Being tested
- Double drains will be placed, A single drain will be placed
- Keywords
- Seroma, Mastectomy, Breast
- Medical subject headings
- Infections, Pain, Postoperative, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double drains will be placedProcedure or surgery
In group A double drains will be placed, one in pectoral region and the other in axillary region.
A single drain will be placedProcedure or surgery
A single drain will be placed in axillary region.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Double Drain) | Active comparator | In group A double drains will be placed, one in pectoral region and the other in axillary region. Receives: Procedure: Double drains will be placed |
| Group B (Single Drain) | Experimental | 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 Receives: Procedure: A single drain will be placed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroma Formation
Collection of fluid at the surgical bed, under the skin, confirmed by ultrasonography
Measured: Post-operative day 1 to day 30
Secondary outcomes (3)
Infection
any signs of infection e.g., Temperature, redness of the skin around incision site, increased total leukocyte count
Measured: 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
Measured: 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
Measured: Post-operative day 1 to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start27 Mar 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seroma Following ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sindh Institute of Urology and Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bushra shirazi, Sindh Institute of Urology and Transplantation
- Investigators
- Bushra Shirazi, FCPS, Principal investigator, Sindh Institute of Urology and Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512141
- Sponsor's protocol ID
- SIUT-ERC-2025/A-577
- Acronym
- SVDD
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the findings/outcomes of the study will be shared
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07512141
- Acronym / sponsor ID
- SVDD / SIUT-ERC-2025/A-577
- Conditions
- Seroma Following Procedure, Infections, Pain, Postoperative
- Keywords
- Seroma, Mastectomy, Breast
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sindh Institute of Urology and TransplantationUniversity, hospital or other
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Group A (Double Drain) | Active comparator | Procedure: Double drains will be placedIn group A double drains will be placed, one in pectoral region and the other in axillary region. |
| Group B (Single Drain) | Experimental | Procedure: A single drain will be placedwhile in group B, a single drain will be placed in axillary region; a 20 Fr JP drain would be used in both the groups |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Mastectomy \& sentinel lymph node biopsy
- Breast reconstruction surgery
- Defect covering flaps
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double drains will be placedIn group A double drains will be placed, one in pectoral region and the other in axillary region. | Procedure or surgery | Group A (Double Drain) |
| A single drain will be placedA single drain will be placed in axillary region. | Procedure or surgery | Group B (Single Drain) |
Primary outcome
Seroma Formation
Time frame: Post-operative day 1 to day 30
Collection of fluid at the surgical bed, under the skin, confirmed by ultrasonography
3 secondary outcomes
Infection
Time frame: Post-operative day 1 to day 30
Duration of drains
Time frame: Post-operative day 1 to day 30
Post-operative pain
Time frame: Post-operative day 1 to day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No. Only the findings/outcomes of the study will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bushra Shirazi, FCPS principal investigator
Sindh Institute of Urology and Transplantation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double drains will be placed and A single drain will be placed in people with Seroma Following Procedure and Infections, run by Sindh Institute of Urology and Transplantation at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Syed Abbas, FCPS (+923331318838, smabbas69@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroma Formation (time frame: Post-operative day 1 to day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.