Seroma Formation After Modified Radical Mastectomy With Flap Fixation Technique in Breast Cancer Patients

Breast-cancer Clinical Trial

Official title:

Seroma Formation After Modified Radical Mastectomy With Flap Fixation Technique in Breast Cancer Patients: Nakhon Phanom Hospital - a Single Blinded Randomized Control Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06243796
• Other study ID #: 39/2566
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: Nakhon Phanom Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the effectiveness of mastectomy flap fixation in breast cancer patients. The main questions it aims to answer are:

• To compare seroma formation after mastectomy flap fixation with conventional surgery in breast cancer patients Participants will be randomly divided into 2 groups,

1. Mastectomy flap fixation

2. Conventional surgery with non flap fixation. Researchers will record the amount and color of drainage fluid, patient and tumor characteristics, and operative related factor after surgery.

Researchers will compare with conventional surgery to see if seroma formation, and wound infection.

Description:

Seroma is collection of blood plasma or lymphatic fluid under skin flap or axillary dead space. It occurred after modified radical mastectomy. Patient will have subcutaneous swelling or edema which be confirmed by physical examination or bedside ultrasound. It categorized by common terminology criteria for adverse events version 5.0 for 3 grades.

1. asymptomatic

2. symptomatic with medical intervention or simple aspiration

3. symptomatic with required interventional radiology or operative intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 68
• Est. completion date: June 30, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Breast cancer (CA Breast) patients plan to modified radical mastectomy

• Operable case, or Resectable case

Exclusion Criteria:

• Having medical bleeding tendency e.g., Idiopathic Thrombocytopenia (ITP), leukemia, other bleeding disorder

• Immunocompromised e.g., HIV, Systemic Lupus Erythematosus (SLE), liver cirrhosis, immunosuppressive drug

• Other modified radical mastectomy whom required reconstruction, flap coverage e.g., Transverse Rectus Abdominis Musculocutaneous (TRAM) flap, Latissimus Dorsi (LD) flap

• Past history of mammoplasty, augmentation

• Past history of axillary lymphatic system operation

• Pregnant women

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast-cancer

Intervention

Procedure:
• Flap fixation technique
After complete the modified radical mastectomy procedure, the researcher will use absorbable sutures (vicryl), multiple alternating stitched 2.5 cm apart between the subcutaneous of the flap and underlying muscle

Locations

Country	Name	City	State
Thailand	Nakhon Phanom hospital	Nakhon Phanom

Sponsors (1)

Lead Sponsor	Collaborator
Nakhon Phanom Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroma formation	Collection of acute inflammatory exudates in response to surgical trauma and acute phase of wound healing.	Every day for 7 days after operation, after discharge 7 days, 15 days, 21 days, 42 days, 63 days, 84 days
Secondary	Wound infection	Any clinical signs and symptoms of wound infection, redness , swelling, wound dehiscence, of Fever > 38 C	Every day for 7 days after operation, after discharge 7 days, 15 days, 21 days, 42 days, 63 days, 84 days