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

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

Study Overview

• Status: Completed
• Conditions: Surgical Flap; Negative-Pressure Dressings
• Intervention / Treatment: Device: NPWT; Other: Conventional dressing

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81511
    • Aswan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• associated severe regional injuries uncontrolled comorbidities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; Conventional dressing is applied over the flaps	Other: Conventional dressing; Conventional dressing ( topical care ) applied to fasciocutaneous flap
Active Comparator: High negative pressure group; A high negative pressure amplitude, (75- 125 mmHg) on continuous mode, is applied over the flaps	Device: NPWT; the NPWT dressing applied to fasciocutaneous flap; Other Names: VAC
Active Comparator: Low negative pressure group; A low negative pressure amplitude, (50- <75 mmHg) on intermittent mode, is applied over the flaps	Device: NPWT; the NPWT dressing applied to fasciocutaneous flap; Other Names: VAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with primary healing	Healing by epithelization without the need for secondary intervention	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with flap Edema	flap edema clinical & radiological assessment	1 week
Number of Participants with flap Congestion	flap congestion clinical assessment	1 week
Number of Participants with flap Ischemia	flap ischemia clinical assessment	1 week
Number of Participants with flap infection	surgical site infection	2 weeks

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: October 8, 2023
• First Submitted That Met QC Criteria: October 8, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Aswan University Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes