Negative Pressure in PAP Donor Sites

Breast Reconstruction Clinical Trial

Official title:

Closed Incision Negative Pressure Therapy in Transverse Donor Site Closure of Free Profunda Artery Perforator Flap for Breast Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05491473
• Other study ID #: 202101649B0
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Breast Reconstruction

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