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OpenTrials
Completed

NCT Number: NCT05491473

Negative Pressure in PAP Donor Sites

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.

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Key information

Conditions

Breast Reconstruction

Sex eligibility

Female

Study type

Observational

Primary location

ChangGungMH

Taoyuan, 33305, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closed incisional negative pressure wound therapy (iNPWT) system

Device

The closed incisional negative pressure wound therapy (iNPWT) system (PREVENA Incision Management System, KCI, an Acelity company, San Antonio, Texas, USA)

Primary outcomes

  1. Off-bed time (days)

    Time frame: post-operative 14 days

  2. Drainage amount (ml)

    Time frame: post-operative 14 days

  3. Vacuum ball removed timing

    Time frame: post-operative 14 days

  4. Vancouver Scar Scale (VSS)

    Time frame: 1 year after surgery

    Score range from 0-13, used to measure scar the scar appearance. The lower means a better outcome.

  5. Re-open

    Time frame: post-operative 14 days

    Whether the patient return to the operation room to check the blood flow or re-do the anastomosis.

  6. Donor site acute complication (< 30 days)

    Time frame: post-operative 30 days

  7. Donor site chronic complication (> 30 days)

    Time frame: 1 year after surgery

  8. Donor site revision

    Time frame: 1 year after surgery

    Whether the patient received scar revision surgery on the donor site where the tissue harvested for breast reconstruction.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 8, 2022
Registry last updated
Aug 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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