Incisional Negative Pressure Wound TherapyNCT04762732
The Use of iNPWT for Management of ALT Flap Donor Site Wound
A study testing NPWT and Traditional wound care in people with Incisional Negative Pressure Wound Therapy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Incisional Negative Pressure Wound Therapy
- What is being tested?
- NPWT and Traditional wound care
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Apr 2021to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Incisional Negative Pressure Wound Therapy for Management of Anterolateral Thigh Flap Donor Site Wound: A Prospective, Randomized Controlled Study
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.
Read the 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.
- Being tested
- NPWT, Traditional wound care
- Keywords
- free flap, head and neck cancer, wound care
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPWTDevice
Wound of ALT donor site will be cared under PREVENA™ Incision Management System for 5 days post-operatively.
Traditional wound careDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: negative pressure wound therapy(PREVENA™ Incision Management System) | Experimental | Wound of ALT donor site will be cared under PREVENA™ Incision Management System Receives: Device: NPWT |
| Placebo Comparator: conventional dressing | Placebo comparator | Wound of ALT donor site will be cared by traditional dressing and care. Receives: Device: Traditional wound care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
donor site scar quality
irst, we will use the Vancouver Scar Scale (VSS) for evaluation at post-operative 6 months. 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start8 Apr 2021
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional Negative Pressure Wound TherapyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nai-Chen Cheng, PhD, Principal investigator, Division of Plastic Surgery, Department of Surgery, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762732
- Sponsor's protocol ID
- 202006043RIPD
- Status last verified
- Oct 2025
- First submitted
- 17 Feb 2021
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Incisional Negative Pressure Wound Therapy for Management of Anterolateral Thigh Flap Donor Site Wound: A Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04762732
- Acronym / sponsor ID
- 202006043RIPD
- Keywords
- free flap, head and neck cancer, wound care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 138 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: negative pressure wound therapy(PREVENA™ Incision Management System) | Experimental | Device: NPWTWound of ALT donor site will be cared under PREVENA™ Incision Management System |
| Placebo Comparator: conventional dressing | Placebo comparator | Device: Traditional wound careWound of ALT donor site will be cared by traditional dressing and care. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPWTWound of ALT donor site will be cared under PREVENA™ Incision Management System for 5 days post-operatively. | Device | Experimental: negative pressure wound therapy(PREVENA™ Incision Management System) |
| Traditional wound careWound of ALT donor site will be covered by vaseline gauze coated with tetracycline ointment (Genuine Chemical Pharmaceutical, Tao-Yuan, Taiwan), and layers of gauze. | Device | Placebo Comparator: conventional dressing |
Primary outcome
Development of wound dehiscence or other wound complications in the ALT flap donor site area
Time frame: 30 days
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.
1 secondary outcome
donor site scar quality
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nai-Chen Cheng, PhD principal investigator
Division of Plastic Surgery, Department of Surgery, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NPWT and Traditional wound care in people with Incisional Negative Pressure Wound Therapy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of wound dehiscence or other wound complications in the ALT flap donor site area (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.