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

Aswan University Hospital65 enrolled

Overview

The goal of this study is to compare the clinical outcomes of using NPWT dressing versus conventional dressing in improving flaps outcome

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Surgical Flap Negative-Pressure Dressings

Interventions

NPWTDEVICE

the NPWT dressing applied to fasciocutaneous flap

Conventional dressingOTHER

Conventional dressing ( topical care ) applied to fasciocutaneous flap

Eligibility

Sex: ALLMin age: 16 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: \- Adult patients skin and soft tissue defects that need flap coverage Exclusion Criteria: * associated severe regional injuries uncontrolled comorbidities

Locations (1)

Aswan University Hospital

Aswān, Egypt

Outcomes

Primary Outcomes

Number of Participants with primary healing

Healing by epithelization without the need for secondary intervention

Time frame: 2 weeks

Secondary Outcomes

Number of Participants with flap Edema

flap edema clinical \& radiological assessment

Time frame: 1 week

Number of Participants with flap Congestion

flap congestion clinical assessment

Time frame: 1 week

Number of Participants with flap Ischemia

flap ischemia clinical assessment

Time frame: 1 week

Number of Participants with flap infection

surgical site infection

Time frame: 2 weeks

Data from ClinicalTrials.gov

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