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

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.

Study Overview

• Status: Completed
• Conditions: Breast Reconstruction
• Intervention / Treatment: Device: Closed incisional negative pressure wound therapy (iNPWT) system

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 33305
    • ChangGungMH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Jung-Ju Huang, MD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Actual): April 10, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: negative pressure; breast reconstruction; profunda artery perforator flap; tensioned wound healing
• Other Study ID Numbers: 202101649B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No