Negative Pressure in PAP Donor Sites
Closed Incision Negative Pressure Therapy in Transverse Donor Site Closure of Free Profunda Artery Perforator Flap for Breast Reconstruction
1 other identifier
observational
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedFirst Submitted
Initial submission to the registry
August 3, 2022
CompletedFirst Posted
Study publicly available on registry
August 8, 2022
CompletedAugust 8, 2022
August 1, 2022
7 months
August 3, 2022
August 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Off-bed time (days)
post-operative 14 days
Drainage amount (ml)
post-operative 14 days
Vacuum ball removed timing
post-operative 14 days
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
Re-open
Whether the patient return to the operation room to check the blood flow or re-do the anastomosis.
post-operative 14 days
Donor site acute complication (< 30 days)
post-operative 30 days
Donor site chronic complication (> 30 days)
1 year after surgery
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
Study Arms (2)
Control
Patients who did not receive the application of iNPWT at the donor site.
Negative pressure
Patients who received the application of iNPWT at the donor site.
Interventions
The closed incisional negative pressure wound therapy (iNPWT) system (PREVENA Incision Management System, KCI, an Acelity company, San Antonio, Texas, USA)
Eligibility Criteria
Patients who received immediate breast reconstruction using PAP flaps by the PI from November 2016 to August 2020.
You may qualify if:
- patients who underwent unilateral microsurgical breast reconstruction using PAP flaps from the PI (JJH) from November 2016 to August 2020
You may not qualify if:
- patients with delayed reconstruction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ChangGungMH
Taoyuan District, 33305, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jung-Ju Huang, MD
Chang Gung Memorial Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 3, 2022
First Posted
August 8, 2022
Study Start
September 23, 2021
Primary Completion
April 10, 2022
Study Completion
May 31, 2022
Last Updated
August 8, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share