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The Negative Pressure Wound Therapy in Flap Enhancement: Clinical Evaluation Study

Negative Pressure Wound Therapy in Flap Enhancement

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06080958
Enrollment
65
Registered
2023-10-12
Start date
2021-05-01
Completion date
2024-03-01
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Flap, Negative-Pressure Dressings

Brief summary

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

Interventions

DEVICENPWT

the NPWT dressing applied to fasciocutaneous flap

Conventional dressing ( topical care ) applied to fasciocutaneous flap

Sponsors

Aswan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Negative pressure wound therapy (vacuum-assisted wound closure) for postoperative flap care

Eligibility

Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

\- Adult patients skin and soft tissue defects that need flap coverage

Exclusion criteria

* associated severe regional injuries uncontrolled comorbidities

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with primary healing2 weeksHealing by epithelization without the need for secondary intervention

Secondary

MeasureTime frameDescription
Number of Participants with flap Edema1 weekflap edema clinical & radiological assessment
Number of Participants with flap Congestion1 weekflap congestion clinical assessment
Number of Participants with flap Ischemia1 weekflap ischemia clinical assessment
Number of Participants with flap infection2 weekssurgical site infection

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026