NCT06080958

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

2.7 years

First QC Date

October 8, 2023

Last Update Submit

July 22, 2024

Conditions

Surgical FlapNegative-Pressure Dressings

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with primary healing

    Healing by epithelization without the need for secondary intervention

    2 weeks

Secondary Outcomes (4)

  • Number of Participants with flap Edema

    1 week

  • Number of Participants with flap Congestion

    1 week

  • Number of Participants with flap Ischemia

    1 week

  • Number of Participants with flap infection

    2 weeks

Study Arms (3)

High negative pressure group

ACTIVE COMPARATOR

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

Device: NPWT

Low negative pressure group

ACTIVE COMPARATOR

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

Device: NPWT

Control group

PLACEBO COMPARATOR

Conventional dressing is applied over the flaps

Other: Conventional dressing

Interventions

NPWTDEVICE

the NPWT dressing applied to fasciocutaneous flap

Also known as: VAC
High negative pressure groupLow negative pressure group
Conventional dressingOTHER

Conventional dressing ( topical care ) applied to fasciocutaneous flap

Control group

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • associated severe regional injuries uncontrolled comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University Hospital

Aswān, 81511, Egypt

Location

Related Publications (1)

  • Elbanna OH, Eldine AS, Sayed AM, Mousa AK. The efficacy and safety of different negative-pressure wound therapy gradients on flaps outcomes. Updates Surg. 2025 Dec;77(8):2643-2651. doi: 10.1007/s13304-025-02156-7. Epub 2025 Mar 23.

    PMID: 40123035DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Negative pressure wound therapy (vacuum-assisted wound closure) for postoperative flap care
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 8, 2023

First Posted

October 12, 2023

Study Start

May 1, 2021

Primary Completion

December 31, 2023

Study Completion

March 1, 2024

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)