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

NCT ID: NCT06080958

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2024-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgical Flap Negative-Pressure Dressings

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Negative pressure wound therapy (vacuum-assisted wound closure) for postoperative flap care
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High negative pressure group

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

Group Type ACTIVE_COMPARATOR

NPWT

Intervention Type DEVICE

the NPWT dressing applied to fasciocutaneous flap

Low negative pressure group

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

Group Type ACTIVE_COMPARATOR

NPWT

Intervention Type DEVICE

the NPWT dressing applied to fasciocutaneous flap

Control group

Conventional dressing is applied over the flaps

Group Type PLACEBO_COMPARATOR

Conventional dressing

Intervention Type OTHER

Conventional dressing ( topical care ) applied to fasciocutaneous flap

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NPWT

the NPWT dressing applied to fasciocutaneous flap

Intervention Type DEVICE

Conventional dressing

Conventional dressing ( topical care ) applied to fasciocutaneous flap

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

VAC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* associated severe regional injuries uncontrolled comorbidities
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aswan University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed Salah Eldin

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aswan University Hospital

Aswān, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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 Mar 23. doi: 10.1007/s13304-025-02156-7. Online ahead of print.

Reference Type DERIVED
PMID: 40123035 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Aswan University Hospital

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

NPWTi on Closure of Chronic Pressure Sores
NCT05598398 RECRUITING PHASE4