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

Aswan University Hospital

Status: Completed

Conditions: Surgical Flap; Negative-Pressure Dressings

Treatments: Device: NPWT; Other: Conventional dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT06080958

Aswan University Hospital

Details and patient eligibility

About

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

Full 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

Enrollment: 65 patients

Sex: All

Ages: 16 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult patients skin and soft tissue defects that need flap coverage

Exclusion criteria

• associated severe regional injuries uncontrolled comorbidities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 3 patient groups, including a placebo group

High negative pressure group

Active Comparator group

Description:

A high negative pressure amplitude, (75- 125 mmHg) on continuous mode, is applied over the flaps

Treatment:

Device: NPWT

Low negative pressure group

Active Comparator group

Description:

A low negative pressure amplitude, (50- \<75 mmHg) on intermittent mode, is applied over the flaps

Treatment:

Device: NPWT

Control group

Placebo Comparator group

Description:

Conventional dressing is applied over the flaps

Treatment:

Other: Conventional dressing