Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06243796
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-07
First Post:
2024-01-29
Brief Title:
Seroma Formation After Modified Radical Mastectomy With Flap Fixation Technique in Breast Cancer Patients
Sponsor:
Nakhon Phanom Hospital
Organization:
Nakhon Phanom Hospital
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
- 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
Detailed 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 50 for 3 grades
1 asymptomatic
2 symptomatic with medical intervention or simple aspiration
3 symptomatic with required interventional radiology or operative intervention
1 asymptomatic
2 symptomatic with medical intervention or simple aspiration
3 symptomatic with required interventional radiology or operative intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None