Clinical trial NCT05491473: Negative Pressure in PAP Donor Sites
Official title: Closed Incision Negative Pressure Therapy in Transverse Donor Site Closure of Free Profunda Artery Perforator Flap for Breast Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Reconstruction
Keywords: breast reconstruction
profunda artery perforator flap
tensioned wound healing
negative pressure
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 25
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received immediate breast reconstruction using PAP flaps by the PI from November 2016 to August 2020.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Off-bed time (days)
timeFrame: post-operative 14 days
measure: Drainage amount (ml)
timeFrame: post-operative 14 days
measure: Vacuum ball removed timing
timeFrame: post-operative 14 days
measure: Vancouver Scar Scale (VSS)
timeFrame: 1 year after surgery
measure: Re-open
timeFrame: post-operative 14 days
measure: Donor site acute complication (< 30 days)
timeFrame: post-operative 30 days
measure: Donor site chronic complication (> 30 days)
timeFrame: 1 year after surgery
measure: Donor site revision
timeFrame: 1 year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: ChangGungMH
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Jung-Ju Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: