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

Not Applicable

Completed

• Conditions: Surgical Flap; Negative-Pressure Dressings
• Interventions: Device: NPWT; Other: Conventional dressing

• Registration Number: NCT06080958
• Lead Sponsor: Aswan University Hospital

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

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2023-10-08
• Study First Submitted QC: 2023-10-08
• Study First Posted: 2023-10-12
• Primary Completion: 2023-12-31
• Study Completion: 2024-03-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

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

Exclusion Criteria

• associated severe regional injuries uncontrolled comorbidities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low negative pressure group	NPWT	A low negative pressure amplitude, (50- \<75 mmHg) on intermittent mode, is applied over the flaps
Control group	Conventional dressing	Conventional dressing is applied over the flaps
High negative pressure group	NPWT	A high negative pressure amplitude, (75- 125 mmHg) on continuous mode, is applied over the flaps

Primary Outcome Measures

Name	Time	Method
Number of Participants with primary healing	2 weeks	Healing by epithelization without the need for secondary intervention

Secondary Outcome Measures

Name	Time	Method
Number of Participants with flap Edema	1 week	flap edema clinical \& radiological assessment
Number of Participants with flap Congestion	1 week	flap congestion clinical assessment
Number of Participants with flap Ischemia	1 week	flap ischemia clinical assessment
Number of Participants with flap infection	2 weeks	surgical site infection

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt