The Negative Pressure Wound Therapy in Flap Salvage

Surgical Flap Clinical Trial

Official title:

Negative Pressure Wound Therapy in Flap Salvage

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06080958
• Other study ID #: Aswan University Hospital
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: November 1, 2024

Study information

• Verified date: June 2024
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to compare the clinical outcomes of using NPWT dressing versus conventional dressing over fasciocutaneous flaps.

Description:

The cases will be divided into 2 major study groups: 1st group will be managed with NPWT and will be divided into 2 subgroups: low pressure therapy and high pressure therapy groups The 2nd group will be managed with conventional dressing

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: November 1, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

Inclusion Criteria:

• Adult patients post-traumatic or post-tumor excision soft tissue defects fascio-cutaneous flaps

Exclusion Criteria:

• associated severe regional injuries uncontrolled comorbidities established flap compromise revision cases

Related Conditions & MeSH terms

• Surgical Flap

Intervention

Device:
• NPWT
the NPWT dressing applied to fasciocutaneous flap

Other:
• Conventional dressing
Conventional dressing ( topical care ) applied to fasciocutaneous flap

Locations

Country	Name	City	State
Egypt	Aswan University Hospital	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with primary healing	Healing by epithelization without the need for secondary intervention	2 weeks
Secondary	Number of Participants with flap Edema	flap edema clinical & radiological assessment	1 week
Secondary	Number of Participants with flap Congestion	flap congestion clinical assessment	1 week
Secondary	Number of Participants with flap Ischemia	flap ischemia clinical assessment	1 week
Secondary	Number of Participants with flap infection	surgical site infection	2 weeks