Negative Pressure in PAP Donor Sites

Completed

• Conditions: Breast Reconstruction
• Interventions: Device: Closed incisional negative pressure wound therapy (iNPWT) system

• Registration Number: NCT05491473
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-23
• Primary Completion: 2022-04-10
• Study Completion: 2022-05-31
• Status Verified: 2022-08
• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-04
• Last Update Submitted: 2022-08-04
• Study First Posted: 2022-08-08
• Last Update Posted: 2022-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Negative pressure	Closed incisional negative pressure wound therapy (iNPWT) system	Patients who received the application of iNPWT at the donor site.

Primary Outcome Measures

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

Trial Locations

Locations (1)

ChangGungMH; 🇨🇳 Taoyuan, Taiwan