Prophylactic Closed Incision Negative Pressure Wound Therapy on Abdominal Wounds - Clinical and Economic Perspectives

NCT04110353 | Withdrawn

• 1 other identifier: 19IC5400
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates whether specialist negative pressure dressings reduce the risk of wound infections after operations when compared to conservative dressings, and if one negative pressure dressings works better than another. The study will look at patients who have had an open operation on their bowel and the wound closed at the end of the operation.

Conditions

Wound Infection; Surgical Site Infection; Surgical Wound; Surgical Incision

Keywords

Surgical Site infections; Negative Pressure Wound Therapy; Contaminated abdominal wounds; Closed incision abdominal wound; Prophylactic therapy

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection

  The occurrence of surgical site infections at the post-operative wound and timeframe of occurrence

  Up to day 90

Secondary Outcomes (14)

• Wound assessments - clinical assessment of presence of wound complication and healing

  At day 7 (on removal of dressing), up to day 30 (on discharge), day 40 (at outpatient follow up)

• Length of stay

  Up to 90 days

• Number of additional interventions received by participants due to development of a Surgical Site Infection

  Within 30 days

• Microscopy, culture and sensitivity results from swabs of any Surgical Site Infections

  Within 30 days

• Post operative complications - other

  Within 30 days

Study Arms (3)

Conservative dressings

ACTIVE COMPARATOR

Use of simple dressings on wound post operatively - to be placed at end of operation

Other: Wound dressings: Conservative dressings

Prevena dressing

ACTIVE COMPARATOR

Use of Prevena(KCI) dressing on wound post operatively - to be placed at end of operation

Other: Wound dressings: Prevena dressings

ciVAC dressing

ACTIVE COMPARATOR

Use of closed incision VAC (vacuum assisted closure) dressing on wound post operatively - to be placed at end of operation

Other: Wound dressings: ciVAC dressings

Interventions

Wound dressings: Conservative dressings OTHER

Conservative dressings to be placed on closed wounds post operatively, after open operations on the bowel. To be changed at day 7 or sooner if clinically indicated.

Conservative dressings

Wound dressings: Prevena dressings OTHER

Prevena dressing to be placed on closed wounds post operatively, after open operations on the bowel. To be changed at day 7 or sooner if clinically indicated.

Prevena dressing

Wound dressings: ciVAC dressings OTHER

Closed incision VAC dressings to be placed on closed wounds post operatively, after open operations on the bowel. To be changed at day 7 or sooner if clinically indicated.

ciVAC dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Emergency, trauma or elective contaminated abdominal operations within general surgery and/or colorectal surgery
• Abdominal wounds closed at time of operation and expected to heal by primary intention
• Patients who have the capacity to consent
• To include complex abdominal wounds with existing infection where wounds have been closed and expected to heal by primary intention
• To including graft or flap sites as part of general surgical procedure
• Patients who are able to complete questionnaires post operatively, either alone or with assistance

You may not qualify if:

• Wounds where an appropriate seal cannot be obtained
• Wounds left open and expected to heal by secondary intention
• Patients known to have allergy or sensitivity to dressings being used
• Patients who lack the capacity to consent

Sponsors & Collaborators

• Imperial College London: lead

MeSH Terms

Conditions

Wound Infection; Surgical Wound Infection; Surgical Wound

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Christopher Peters

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Carolynne Vaizey

  St Mark's Hospital and Academic Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped wedge design with randomisation at the level of the Hospitals not individual patients

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: October 1, 2019
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share