NPWTPhase 1NCT02442401
Role of Negative Pressure Wound Therapy in Latissimus Dorsi Flap Donor Site Seroma Prevention
A Phase 1 study testing The negative pressure wound therapy in people with NPWT and Latissimus Dorsi Flap, run by Chulalongkorn University.
Trial summary
The use of NPWT as a post-operative dressing significantly reduces the incidence of seroma formation after harvesting LD flap. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- NPWT, Latissimus Dorsi Flap, Breast Reconstruction
- What is being tested?
- The negative pressure wound therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Dec 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20-60 years Underwent breast reconstruction with LD Flap
Who cannot join
- Locally advanced cancer
About this study
The use of NPWT as a post-operative dressing significantly reduces the incidence of seroma formation after harvesting LD flap.
Read the detailed description
NPWT was left in place on donor site with constant pressure between -125 and -80 mmHg to reduce seroma formation
- Conditions
- NPWT, Latissimus Dorsi Flap, Breast Reconstruction
- Being tested
- The negative pressure wound therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The negative pressure wound therapyDevice
Also called NPWT
| Study group | Role | What they receive |
|---|---|---|
| NPWT group | Experimental | Negative pressure wound therapy was used to prevent donor site seroma formation Receives: Device: The negative pressure wound therapy |
| Control group | No intervention | Conventional method was used to the donor site |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of seroma
Measured: 3 months
Secondary outcomes (2)
Aspirated Volume
Measured: 3 months
Frequency of Aspiration
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startJan 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NPWTStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Thana Laopiyasakul, Pornthep Pungrasmi, Poonpissamai Suwajo
- Responsible party
- Principal investigator, Apichai Angspatt, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442401
- Sponsor's protocol ID
- 030/55
- Status last verified
- May 2015
- First submitted
- 10 May 2015
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Negative Pressure Wound Therapy in Latissimus Dorsi Flap Donor Site Seroma Prevention
- ClinicalTrials.gov ID
- NCT02442401
- Acronym / sponsor ID
- 030/55
- Conditions
- NPWT, Latissimus Dorsi Flap, Breast Reconstruction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Thana Laopiyasakul, Pornthep Pungrasmi, Poonpissamai Suwajo
- Study start
- Jan 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 May 2015 (estimated)
- 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.
The use of NPWT as a post-operative dressing significantly reduces the incidence of seroma formation after harvesting LD flap.
Detailed description
NPWT was left in place on donor site with constant pressure between -125 and -80 mmHg to reduce seroma formation
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPWT group | Experimental | Device: The negative pressure wound therapyNegative pressure wound therapy was used to prevent donor site seroma formation |
| Control group | No intervention | –Conventional method was used to the donor site |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age between 20-60 years Underwent breast reconstruction with LD Flap
Key exclusion criteria (1 listed)
- Locally advanced cancer
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 |
|---|---|---|
| The negative pressure wound therapyAlso: NPWT | Device | NPWT group |
Primary outcome
Incidence of seroma
Time frame: 3 months
2 secondary outcomes
Aspirated Volume
Time frame: 3 months
Frequency of Aspiration
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing The negative pressure wound therapy in people with NPWT and Latissimus Dorsi Flap, run by Chulalongkorn University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of seroma (time frame: 3 months). 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 15 May 2015.