NCT06964516

A Prospective Randomized Controlled Study on Minimally Invasive Breast Effects Between the Modified Local Compression Bandaging Method and the Traditional Whole Breast Compression Bandaging Method

Not yet recruiting NA Last updated 9 May 2025

What this trial tests

NA trial testing The group using the whole-breast bandaging method in Minimally Invasive Mammary Gland Vacuum-Assisted Biopsy in 312 participants. Not yet recruiting.

Timeline

1 May 2025

Primary endpoint
1 January 2026

22 January 2026

Quick facts

Lead sponsor	Guangdong Provincial People's Hospital
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	312
Start date	1 May 2025
Primary completion	1 January 2026
Estimated completion	22 January 2026

Drugs / interventions tested

• The group using the whole-breast bandaging method
• The group using the local bandaging method

Conditions studied

• Minimally Invasive Mammary Gland Vacuum-Assisted Biopsy — all drugs for Minimally Invasive Mammary Gland Vacuum-Assisted Biopsy →

Sponsor

Guangdong Provincial People's Hospital

Who can join

Adults 18 to 70, female only, with Minimally Invasive Mammary Gland Vacuum-Assisted Biopsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

I. Research Background Due to the relatively large trauma to the breast caused by traditional general anesthesia surgery, long recovery time, high incidence of postoperative complications, and patients' fear of general anesthesia surgery, the Mammotome minimally invasive rotary excision surgery has emerged. This minimally invasive breast surgery has very prominent advantages, mainly manifested as visualization, small incisions, and safety and reliability.

Currently, the commonly used bandaging method after minimally invasive breast surgery in clinical practice is the whole-breast compression bandaging method. One or two sterile loose gauze pieces are kneaded into a gauze ball and pressed on the residual cavity. Then, 5 to 8 loose gauze pieces are continuously stacked with the gauze ball within a 5 cm diameter around the wound for bandaging. Finally, an elastic bra is used for another day of compression bandaging. The elastic bra is a special compression elastic bandage for postoperative breast use to achieve auxiliary therapeutic effects such as clearing the cavity and protecting the surgical incision.

However, in the process of clinical practice, it has been found that this bandaging method brings great discomfort to patients. It is not only reflected in varying degrees of skin itching on the covered skin, and there are many cases of local red rashes. Moreover, it affects the patients' breathing. The vast majority of patients complain of pain and discomfort caused by the tight binding on the chest and back, feeling restless when sitting or lying down. At night, they can only sleep in a semi-sitting position and are largely unable to enter a deep sleep, seriously affecting the patients' daily activities and sleep conditions.

In order to improve the patients' experience and reduce their discomfort as much as possible, the medical and nursing joint team explored and improved the compression bandaging method after minimally invasive surgery and found that the local compression bandaging method is more comfortable. That is, one or two loose gauze pieces are kneaded into a gauze ball to replace multiple gauze balls and placed at the residual cavity. Then, elastic medical adhesive tape is used for local compression and sticking. Finally, a pure cotton clean towel is placed inside the elastic bra, and the elastic bra is worn for one day.

According to the results of a pre-experiment involving 50 cases, among the patients using the local compression bandaging method, there was no occurrence of wound hematoma, and their skin itching, chest and back pain, comfort level, and sleep conditions were all improved. In order to further compare the application effects of the whole-breast compression bandaging method and the local compression bandaging method, the research team of this study intends to conduct a comparative study of the two methods.

II. Research Objectives Research Objectives: Through a randomized controlled study, compare and study the curative effects of two different bandaging methods, namely the whole-breast bandaging method and the local bandaging method, during the perioperative period of minimally invasive breast surgery. Evaluate the impacts of the two bandaging methods on the wound healing situation after minimally invasive breast surgery, the incidence of hematoma, the patients' comfort level, and the incidence of patients' pain.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.