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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,
Researchers will compare with conventional surgery to see if seroma formation, and wound infection.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flap fixation | Experimental | After completing the modified radical mastectomy procedure, the researcher will use absorbable suture (vicryl), multiple alternating stitches 2.5 cm apart between the subcutaneous tissues of the skin flaps and the underlying muscles at various parts of the flap and also, at the wound edge. |
|
| Non flap fixation | No Intervention | After mastectomy, the researcher will close the wound in the conventional method. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flap fixation technique | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Seroma Formation | Every day for 7 days post operative period, fluid from drains was recorded (ml) daily. After discharge during follow up period, seroma formation was observed if seroma was observed, aspiration was performed and recorded. | Every day for 7 days post operative period and after discharge 7, 15, 21, 42, 63, 84 days during follow up period. |
| Measure | Description | Time Frame |
|---|---|---|
| Complication After Surgery 1. Wound Infection 2. Joint Stiffness 3. Visit Before the Appointment Date |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natawan Hunpayon, MD | Nakhon Phanom Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nakhon Phanom hospital | Nakhon Phanom | 48000 | Thailand |
De-identify data
1 year after publication for a period of 2 years
Access to trial Individual Patient Data (IPD) can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of research proposal and statistical analysis plan (SAP) and execution of Data Sharing Agreement (DSA). For more information or to submit a request, please contact e-mail: sutthichain@gmail.com.
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Excluded accidental finding liver cirrhosis before surgery (n=1), plan to move another province (n=1)
A single-blinded randomized control trial was conducted between December 2023 to June 2024. All operable breast cancer patients who were 18 years old and over, early and locally advance breast cancer who underwent modified radical mastectomy by single surgeon in Nakhonphanom hospital were screened
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| ID | Title | Description |
|---|---|---|
| FG000 | Flap Fixation (n=34) | After completing the modified radical mastectomy procedure, the researcher will use absorbable suture (vicryl), multiple alternating stitches 2.5 cm apart between the subcutaneous tissues of the skin flaps and the underlying muscles at various parts of the flap and also, at the wound edge. 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 |
| FG001 | Non Flap Fixation (n=34) | After mastectomy, the researcher will close the wound in the conventional method. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Flap Fixation | Average age was 53±14 years. 13 patients with class I obesity (BMI > 25kg/m2) and above. 5 (14.7%)patients received neoadjuvant chemotherapy. Average operative time were 57±10 minutes. Average blood loss was 33.53±13.23 ml. Most of breast cancer cell type in this group was invasive ductal carcinoma = 32. Average tumor size in group A was 3.5 cm. Most of patients in this group were diagnosed in stage 2A, 14(41.18%).1 patients had distance metastasis, (2.94%). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years, Continuous |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Seroma Formation | Every day for 7 days post operative period, fluid from drains was recorded (ml) daily. After discharge during follow up period, seroma formation was observed if seroma was observed, aspiration was performed and recorded. | Analysis population is patients whom randomized were performed operation as randomized and have data during follow up period. | Posted | Mean | Standard Deviation | ml | Every day for 7 days post operative period and after discharge 7, 15, 21, 42, 63, 84 days during follow up period. |
|
3 months after operation
wound infection, joint stiffness, visit before appointment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flap Fixation (n=34) | After completing the modified radical mastectomy procedure, the researcher will use absorbable suture (vicryl), multiple alternating stitches 2.5 cm apart between the subcutaneous tissues of the skin flaps and the underlying muscles at various parts of the flap and also, at the wound edge. 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound infection | Infections and infestations | Non-systematic Assessment | surgical wound infection, joint stiffness |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Kriengkrai Prasert | Nakhon Phanom hospital | +6642199222 | 1091 | gpsiam28@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2023 | Jan 12, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Single blinded randomized control trial
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The statistician will generate randomization list from block randomization, then concealed envelope
| Data were assessed 7 days after operation, after discharge 7 days, 15 days, 21 days, 42 days, 63 days, 84 days. Data from any time point were combined by counted and sum number of specific outcome of interest. |
| BG001 | Non Flap Fixation | Average 58±10 years. 13 patients with class I obesity (BMI > 25kg/m2) and above. 9 (26.47%) patients received neoadjuvant chemotherapy. Average operative time was 58±10 minutes. Average blood loss was 35.88±17.60 ml. Most of breast cancer cell type in this group was invasive ductal carcinoma = 31 Average tumor size 4.09 cm. Most of patients in this group were diagnosed in stage 2A, 12 (35.29%). 4 (11.76%) patients had distance metastasis. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Nakhon Phanom hospital, Thailand | Number | participants |
|
| Co-morbidity | Had one or more underlying medical conditions | Count of Participants | Participants |
|
| Body mass index | Body mass index (Body weight)kg/(Height)m2 | Mean | Standard Deviation | kg/m2 |
|
| Neo-adjuvant chemotherapy | Received neo-adjuvant chemotherapy before surgery | Count of Participants | Participants |
|
| OG001 | Non Flap Fixation | After mastectomy, the researcher will close the wound in the conventional method. |
|
|
|
| Secondary | Complication After Surgery 1. Wound Infection 2. Joint Stiffness 3. Visit Before the Appointment Date |
| Posted | Count of Participants | Participants | Data were assessed 7 days after operation, after discharge 7 days, 15 days, 21 days, 42 days, 63 days, 84 days. Data from any time point were combined by counted and sum number of specific outcome of interest. |
|
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 3 |
| 34 |
| EG001 | Non Flap Fixation (n=34) | After mastectomy, the researcher will close the wound in the conventional method. | 0 | 34 | 0 | 34 | 10 | 34 |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Limitation of movement of should joint |
|
| visit before appointment | Injury, poisoning and procedural complications | Non-systematic Assessment | any visit before appointment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| visit before follow up date |
|