Surgical FlapNCT06080958
The Negative Pressure Wound Therapy in Flap Enhancement: Clinical Evaluation Study
A study testing NPWT and Conventional dressing in people with Surgical Flap and Negative-Pressure Dressings, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
The goal of this study is to compare the clinical outcomes of using NPWT dressing versus conventional dressing in improving flaps outcome Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Flap, Negative-Pressure Dressings
- What is being tested?
- NPWT and Conventional dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 1 Mar 2024
- Phase
- Interventional
- 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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adult patients skin and soft tissue defects that need flap coverage
Who cannot join
- associated severe regional injuries uncontrolled comorbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Negative Pressure Wound Therapy in Flap Enhancement
The goal of this study is to compare the clinical outcomes of using NPWT dressing versus conventional dressing in improving flaps outcome
Read the detailed description
The cases will be divided into 3 major study groups:
1st group will be managed with high negative pressure wound therapy The 2nd group will be managed with low negative pressure wound therapy The 3rd group will be managed with conventional dressing
- Conditions
- Surgical Flap, Negative-Pressure Dressings
- Being tested
- NPWT, Conventional dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPWTDevice
Also called VAC
the NPWT dressing applied to fasciocutaneous flap
Conventional dressingOther
Conventional dressing ( topical care ) applied to fasciocutaneous flap
| Study group | Role | What they receive |
|---|---|---|
| High negative pressure group | Active comparator | A high negative pressure amplitude, (75- 125 mmHg) on continuous mode, is applied over the flaps Receives: Device: NPWT |
| Low negative pressure group | Active comparator | A low negative pressure amplitude, (50- <75 mmHg) on intermittent mode, is applied over the flaps Receives: Device: NPWT |
| Control group | Placebo comparator | Conventional dressing is applied over the flaps Receives: Other: Conventional dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with primary healing
Healing by epithelization without the need for secondary intervention
Measured: 2 weeks
Secondary outcomes (4)
Number of Participants with flap Edema
flap edema clinical \& radiological assessment
Measured: 1 week
Number of Participants with flap Congestion
flap congestion clinical assessment
Measured: 1 week
Number of Participants with flap Ischemia
flap ischemia clinical assessment
Measured: 1 week
Number of Participants with flap infection
surgical site infection
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 May 2021
- Primary completion31 Dec 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical FlapStudies of the same condition, open and under way.
- 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
- Model description
- Negative pressure wound therapy (vacuum-assisted wound closure) for postoperative flap care
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Salah Eldin, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080958
- Sponsor's protocol ID
- Aswan University Hospital
- Status last verified
- Jul 2024
- First submitted
- 8 Oct 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Elbanna OH, Eldine AS, Sayed AM, Mousa AK. The efficacy and safety of different negative-pressure wound therapy gradients on flaps outcomes. Updates Surg. 2025 Dec;77(8):2643-2651. doi: 10.1007/s13304-025-02156-7. Epub 2025 Mar 23.
PubMed 40123035
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Pressure Wound Therapy in Flap Enhancement
- ClinicalTrials.gov ID
- NCT06080958
- Acronym / sponsor ID
- Aswan University Hospital
- Conditions
- Surgical Flap, Negative-Pressure Dressings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 12 Oct 2023 (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.
The goal of this study is to compare the clinical outcomes of using NPWT dressing versus conventional dressing in improving flaps outcome
Detailed description
The cases will be divided into 3 major study groups:
1st group will be managed with high negative pressure wound therapy The 2nd group will be managed with low negative pressure wound therapy The 3rd group will be managed with conventional dressing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Negative pressure wound therapy (vacuum-assisted wound closure) for postoperative flap care
| Arm | Type | Receives |
|---|---|---|
| High negative pressure group | Active comparator | Device: NPWTA high negative pressure amplitude, (75- 125 mmHg) on continuous mode, is applied over the flaps |
| Low negative pressure group | Active comparator | Device: NPWTA low negative pressure amplitude, (50- <75 mmHg) on intermittent mode, is applied over the flaps |
| Control group | Placebo comparator | Other: Conventional dressingConventional dressing is applied over the flaps |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adult patients skin and soft tissue defects that need flap coverage
Key exclusion criteria (1 listed)
- associated severe regional injuries uncontrolled comorbidities
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 |
|---|---|---|
| NPWTAlso: VACthe NPWT dressing applied to fasciocutaneous flap | Device | High negative pressure group, Low negative pressure group |
| Conventional dressingConventional dressing ( topical care ) applied to fasciocutaneous flap | Other | Control group |
Primary outcome
Number of Participants with primary healing
Time frame: 2 weeks
Healing by epithelization without the need for secondary intervention
4 secondary outcomes
Number of Participants with flap Edema
Time frame: 1 week
Number of Participants with flap Congestion
Time frame: 1 week
Number of Participants with flap Ischemia
Time frame: 1 week
Number of Participants with flap infection
Time frame: 2 weeks
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 23 Jul 2024.
- Derived from this study: PubMed 40123035Elbanna OH, Eldine AS, Sayed AM, Mousa AK. The efficacy and safety of different negative-pressure wound therapy gradients on flaps outcomes. Updates Surg. 2025 Dec;77(8):2643-2651. doi: 10.1007/s13304-025-02156-7. Epub 2025 Mar 23.
- Individual participant dataSharing planned: No
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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.
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 Conventional dressing in people with Surgical Flap and Negative-Pressure Dressings, run by Aswan University Hospital at 1 site in Egypt.
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 23 Jul 2024. 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 Egypt. 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?
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?
Number of Participants with primary healing (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06080958, which also lists 1 linked publication.
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 23 Jul 2024.