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The Use of iNPWT for Management of ALT Flap Donor Site Wound

Primary Purpose

Incisional Negative Pressure Wound Therapy

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
NPWT
Traditional wound care
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incisional Negative Pressure Wound Therapy focused on measuring free flap, head and neck cancer, wound care

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

The study is designed as a prospective randomized clinical trial. This study aims to enroll patients who require a free ALT flap for head and neck reconstruction. Inclusion criteria are as follows:

  1. The donor site of ALT flap can be closed primarily.
  2. Age≥20 years and <80 years
  3. ALT flap size measuring more than 6 cm in width
  4. Patients will be required to understand and be willing to participate in the trial and be able to comply with the follow-up visits

Exclusion criteria are as follows:

  1. he donor site of ALT flap can not be closed primarily.
  2. Uncontrolled diabetes mellitus, as measured by HbA1c≥10%
  3. Under renal replacement therapy for more than 1 year.
  4. Pregnant woman

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: negative pressure wound therapy (PREVENA™ Incision Management System)

Placebo Comparator: conventional dressing

Arm Description

Wound of ALT donor site will be cared under PREVENA™ Incision Management System

Wound of ALT donor site will be cared by traditional dressing and care.

Outcomes

Primary Outcome Measures

Development of wound dehiscence or other wound complications in the ALT flap donor site area
Development of wound dehiscence or other wound complications in the ALT flap donor site area during the first 6 weeks postoperatively. Wound dehiscence is defined as the splitting apart or rupturing of the margins of a previously closed wound along some or all of its length. Surgical site infection (SSI) was reported according to the revised criteria outlined by the Centers for Disease Control and Prevention (CDC), USA. To achieve a higher degree of objectivity, we will also adopt the modified ASEPSIS score criteria and definitions. The primary outcomes are assessed at the standardized follow-up visits by nurses and physicians in the hospital or in the outpatient clinic, who are not connected to the study and blinded to dressing allocation. The presence of dehiscence/infection at the ALT flap donor site, total or partial skin graft loss, and the need for another surgical procedure to the donor site are recorded.

Secondary Outcome Measures

donor site scar quality
irst, we will use the Vancouver Scar Scale (VSS) for evaluation at post-operative 12 weeks. The VSS assesses four variables: vascularity, height/thickness, pliability and pigmentation. Each variable includes ranked subscales that are summed to obtain a total score ranging from 0 to 13, with 0 representing normal skin and 13 representing maximum alterations of the skin. The Patient and Observer Scar Assessment Scale (POSAS), which is a reliable and consistent tool used to assess scar quality, will also be employed.

Full Information

First Posted
February 17, 2021
Last Updated
February 21, 2021
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04762732
Brief Title
The Use of iNPWT for Management of ALT Flap Donor Site Wound
Official Title
The Use of Incisional Negative Pressure Wound Therapy for Management of Anterolateral Thigh Flap Donor Site Wound: A Prospective, Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary closure or skin grafting of the donor site after harvest of a anterolateral thigh flap (ALT) is associated with significant morbidity. Incisional negative pressure wound therapy (NPWT) may decrease complications in high-risk incisions. Successful use of NPWT has been reported in the treatment of ALT flap donor site wounds in a retrospective observational study, but no prospective study of NPWT application in the ALT flap donor site has been reported. This study aims to assess the incidence of complications at ALT flap donor site with an incisional NPWT device, PREVENA™. A prospective, controlled, pair-matched study has been designed to compare the effectiveness, complication rate, and scar quality of ALT flap donor site between using incisional NPWT and conventional bolster dressing.
Detailed Description
Primary closure or skin grafting of the donor site after harvest of a anterolateral thigh flap (ALT) is associated with significant morbidity. Incisional negative pressure wound therapy (NPWT) may decrease complications in high-risk incisions. Successful use of NPWT has been reported in the treatment of ALT flap donor site wounds in a retrospective observational study, but no prospective study of NPWT application in the ALT flap donor site has been reported. This study aims to assessed the incidence of complications at ALT flap donor site with an incisional NPWT device, PREVENA™. A prospective, controlled, pair-matched study has been designed to compare the effectiveness, complication rate, and scar quality of ALT flap donor site between using incisional NPWT and conventional bolster dressing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Negative Pressure Wound Therapy
Keywords
free flap, head and neck cancer, wound care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: negative pressure wound therapy (PREVENA™ Incision Management System)
Arm Type
Experimental
Arm Description
Wound of ALT donor site will be cared under PREVENA™ Incision Management System
Arm Title
Placebo Comparator: conventional dressing
Arm Type
Placebo Comparator
Arm Description
Wound of ALT donor site will be cared by traditional dressing and care.
Intervention Type
Device
Intervention Name(s)
NPWT
Intervention Description
Wound of ALT donor site will be cared under PREVENA™ Incision Management System for 5 days post-operatively.
Intervention Type
Device
Intervention Name(s)
Traditional wound care
Intervention Description
Wound of ALT donor site will be covered by vaseline gauze coated with tetracycline ointment (Genuine Chemical Pharmaceutical, Tao-Yuan, Taiwan), and layers of gauze.
Primary Outcome Measure Information:
Title
Development of wound dehiscence or other wound complications in the ALT flap donor site area
Description
Development of wound dehiscence or other wound complications in the ALT flap donor site area during the first 6 weeks postoperatively. Wound dehiscence is defined as the splitting apart or rupturing of the margins of a previously closed wound along some or all of its length. Surgical site infection (SSI) was reported according to the revised criteria outlined by the Centers for Disease Control and Prevention (CDC), USA. To achieve a higher degree of objectivity, we will also adopt the modified ASEPSIS score criteria and definitions. The primary outcomes are assessed at the standardized follow-up visits by nurses and physicians in the hospital or in the outpatient clinic, who are not connected to the study and blinded to dressing allocation. The presence of dehiscence/infection at the ALT flap donor site, total or partial skin graft loss, and the need for another surgical procedure to the donor site are recorded.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
donor site scar quality
Description
irst, we will use the Vancouver Scar Scale (VSS) for evaluation at post-operative 12 weeks. The VSS assesses four variables: vascularity, height/thickness, pliability and pigmentation. Each variable includes ranked subscales that are summed to obtain a total score ranging from 0 to 13, with 0 representing normal skin and 13 representing maximum alterations of the skin. The Patient and Observer Scar Assessment Scale (POSAS), which is a reliable and consistent tool used to assess scar quality, will also be employed.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The study is designed as a prospective randomized clinical trial. This study aims to enroll patients who require a free ALT flap for head and neck reconstruction. Inclusion criteria are as follows: The donor site of ALT flap can be closed primarily. Age≥20 years and <80 years ALT flap size measuring more than 6 cm in width Patients will be required to understand and be willing to participate in the trial and be able to comply with the follow-up visits Exclusion criteria are as follows: he donor site of ALT flap can not be closed primarily. Uncontrolled diabetes mellitus, as measured by HbA1c≥10% Under renal replacement therapy for more than 1 year. Pregnant woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yin Cheng, MD
Phone
phone
Email
a_7762099@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nai-Chen Cheng, PhD
Organizational Affiliation
Division of Plastic Surgery, Department of Surgery, National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nai-Chen Cheng
Phone
02-23123456
Ext
65068
Email
nccheng@ntu.edu.tw

12. IPD Sharing Statement

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The Use of iNPWT for Management of ALT Flap Donor Site Wound

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