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The Negative Pressure Wound Therapy in Flap Salvage

Sponsor
Aswan University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06080958
Collaborator
(none)
40
Enrollment
1
Location
3
Arms
15
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: NPWT
  • Other: Conventional dressing
 N/A

Detailed 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

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Negative pressure wound therapy (vacuum-assisted wound closure) for postoperative flap careNegative pressure wound therapy (vacuum-assisted wound closure) for postoperative flap care
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Negative Pressure Wound Therapy in Flap Salvage
Actual Study Start Date :
Aug 1, 2022
Actual Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: High negative pressure group

A high negative pressure amplitude 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 is applied over the flaps

    Device: NPWT
    the NPWT dressing applied to fasciocutaneous flap
    Other Names:
  • VAC

    		•
    Placebo Comparator: Control group

    Conventional dressing is applied over the flaps

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

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with primary healing [2 weeks]

      Healing by epithelization without the need for secondary intervention

    Secondary Outcome Measures

    1. Number of Participants with flap Edema [1 week]

      flap edema clinical & radiological assessment

    2. Number of Participants with flap Congestion [1 week]

      flap congestion clinical assessment

    3. Number of Participants with flap Ischemia [1 week]

      flap ischemia clinical assessment

    4. Number of Participants with flap infection [2 weeks]

      surgical site infection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aswan University Hospital Aswan Egypt 81511

    Sponsors and Collaborators

    • Aswan University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Salah Eldin, principal investigator, Aswan University Hospital
    ClinicalTrials.gov Identifier:
    NCT06080958
    Other Study ID Numbers:
    • Aswan University Hospital
    First Posted:
    Oct 12, 2023
    Last Update Posted:
    Oct 16, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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

    Study Results

    No Results Posted as of Oct 16, 2023