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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05491473
Other study ID # 202101649B0
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 23, 2021
Est. completion date May 31, 2022

Study information

Verified date August 2022
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A retrospective chart review will be conducted to identify patients who received breast reconstruction using free profunda artery perforator (PAP) flap by the investigators from January 2015 to August 2021. The included patients will be grouped into two according to the application of incisional negative pressure wound therapy (NP) on the donor site. Patients' demographic data including their age at the surgery, body mass index (BMI), medical comorbidities including the hypertension and diabetes, and smoking history will be obtained from the retrospective chart review. Parameters of the flap will be carefully reviewed, including the flap harvested width, and flap harvested length, the flap harvested and used size, the size of the mastectomy, the ischemia time of the flap. The major interest is in the donor site management and patient's overall recovery. The complications of the donor site will be categorized into acute and chronic ones depending on the time of presence. Donor site complications, such as wound break down, hematoma, seroma, the total amount of the drainage will be recorded. The cutting time point for acute and chronic complications is 1 month. The total amount of drainage from the drainage tube inserted and the patients' off-bed time (day) will also be recorded. Besides, for patients with follow up time of more than 1 year, the scar will be evaluated using Vancouver scar scale. Statistics Data will be analyzed using graphing and statistical analysis software SPSS 21 software (IBM, Chicago, Illinois, USA). Rank sum and independent t test will be applied to calculate continuous variables in demographic values, while Chi-square will be applied to calculate categorical variables such as postoperative complications. A probability of less than 0.05 will be considered significant. Potential risks: No Confidentiality: All the patient identifiable information, which includes name, chart number and birthday, involved in the study will be strictly confidential.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date May 31, 2022
Est. primary completion date April 10, 2022
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - patients who underwent unilateral microsurgical breast reconstruction using PAP flaps from the PI (JJH) from November 2016 to August 2020 Exclusion Criteria: - patients with delayed reconstruction

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Closed incisional negative pressure wound therapy (iNPWT) system
The closed incisional negative pressure wound therapy (iNPWT) system (PREVENA Incision Management System, KCI, an Acelity company, San Antonio, Texas, USA)

Locations

Country Name City State
Taiwan ChangGungMH Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Off-bed time (days) post-operative 14 days
Primary Drainage amount (ml) post-operative 14 days
Primary Vacuum ball removed timing post-operative 14 days
Primary Vancouver Scar Scale (VSS) Score range from 0-13, used to measure scar the scar appearance. The lower means a better outcome. 1 year after surgery
Primary Re-open Whether the patient return to the operation room to check the blood flow or re-do the anastomosis. post-operative 14 days
Primary Donor site acute complication (< 30 days) post-operative 30 days
Primary Donor site chronic complication (> 30 days) 1 year after surgery
Primary Donor site revision Whether the patient received scar revision surgery on the donor site where the tissue harvested for breast reconstruction. 1 year after surgery
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