Infections, Pain, Postoperative, Seroma Following Procedure
Conditions
Keywords
Seroma, Mastectomy, Breast
Brief 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
Interventions
PROCEDUREDouble drains will be placed
In group A double drains will be placed, one in pectoral region and the other in axillary region.
PROCEDUREA single drain will be placed
A single drain will be placed in axillary region.
Sponsors
Sindh Institute of Urology and Transplantation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroma Formation | Post-operative day 1 to day 30 | Collection of fluid at the surgical bed, under the skin, confirmed by ultrasonography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection | Post-operative day 1 to day 30 | any signs of infection e.g., Temperature, redness of the skin around incision site, increased total leukocyte count |
| Duration of drains | Post-operative day 1 to day 30 | 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 |
| Post-operative pain | Post-operative day 1 to day 30 | 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 |
Countries
Pakistan
Contacts
CONTACTSyed Abbas, FCPS
CONTACTBushra Shirazi, FCPS
PRINCIPAL_INVESTIGATORBushra Shirazi, FCPS
Sindh Institute of Urology and Transplantation
Outcome results
None listed