NCT06025253

Brief Summary

Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. This study is taking place to investigate if Negative Pressure Wound Therapy (NPWT) dressings reduces Surgical Site Infections, post surgical complications and improves scar appearance compared to standard dressings.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
728

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

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 Progress78%
Mar 2024Dec 2026

First Submitted

Initial submission to the registry

August 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2026

Expected
Last Updated

October 18, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

August 29, 2023

Last Update Submit

October 16, 2024

Conditions

Wound SurgicalWound InfectionCosmesis

Keywords

Negative Pressure Wound TherapySurgical Site InfectionPost-operative ComplicationsHealth EconomicsCoPaQWoundQol

Outcome Measures

Primary Outcomes (1)

  • Presence of wound complications following amputation between NPWT and standard dressings

    Infection(deep or superficial), wound dehiscence, partial (fascia intact), complete (fascia breached), seroma, haematoma or stump necrosis.

    1 month following surgery

Secondary Outcomes (13)

  • Number of days to discharge

    6 months following surgery

  • Rate of re-admission

    1 Month following surgery

  • Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)

    Baseline

  • Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)

    1 month following surgery

  • Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)

    3 months following surgery

  • +8 more secondary outcomes

Study Arms (2)

Negative Pressure Wound Therapy.

EXPERIMENTAL

Application of a negative wound pressure therapy dressing to the wound post major lower extremity amputation

Device: Negative Pressure Wound Therapy

Standard Wound dressing

ACTIVE COMPARATOR

Application of sterile standard gauze dressing to the wound post major lower extremity amputation

Device: Standard Wound Dressing

Interventions

Negative Pressure Wound TherapyDEVICE

Application of negative-pressure wound therapy (NPWT) post major lower extremity amputation

Negative Pressure Wound Therapy.
Standard Wound DressingDEVICE

Application of standard wound dressing post major lower extremity amputation

Standard Wound dressing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years or older;
  • Patients undergoing major lower extremity amputation, including below-knee amputation, through-knee amputation and above-knee amputation, for any indication;
  • Patients with primary closure of the surgical incision using either interrupted or continuous sutures

You may not qualify if:

  • Patients \<18 years;
  • Women who are pregnant and/or breast-feeding;
  • Patients with amputations performed without primary skin closure, including guillotine amputations, amputations deliberately left open for drainage purposes and amputations with soft tissues defects at the stump;
  • Patients with amputations where skin glue is the only means of skin closure
  • Patients with a clinically absent femoral pulse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Beaumont Hospital, Beaumont rd,Dublin 9, D09V2N0

Dublin, H91 YR71, Ireland

NOT YET RECRUITING

St Jamess Hospital

Dublin, Ireland

NOT YET RECRUITING

St Vincents University Hospital

Dublin, Ireland

NOT YET RECRUITING

Tallaght University Hospital

Dublin, Ireland

NOT YET RECRUITING

University Hospital Galway

Galway, Ireland

RECRUITING

University Hospital Limerick

Limerick, Ireland

NOT YET RECRUITING

University Hospital Waterford

Waterford, Ireland

RECRUITING

MeSH Terms

Conditions

Surgical WoundWound InfectionSurgical Wound Infection

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Wounds and InjuriesInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Study Officials

  • Stewart Walsh, Prof

    University Hospital Galway (UHG)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stewart Walsh

CONTACT

353 915 2422stewartredmond.walsh@universityofgalway.ie

Megan Foley

CONTACT

353 915 2422meganpfoley@rcsi.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 6, 2023

Study Start

March 1, 2024

Primary Completion

March 1, 2026

Study Completion (Estimated)

December 20, 2026

Last Updated

October 18, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

IE(7)