Development of Volatile Organic Compounds (VOC) Analysis as a Potential Diagnostic for Infected and Non-Healing Wounds

NCT05154838 | Completed

• 2 other identifiers: 7864302788
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to assess the feasibility of detecting volatile organic compounds (VOCs) from pilonidal wound dressings to assemble a VOC profile for the assessment of wound healing trends. Non-healing wounds (NHWs) pose a significant burden to healthcare providers and to affected patients. Difficulties arise in the identification of wounds which are not on a healing trajectory. Early identification allows for proactive management to try and reduce healing time. Recent studies indicate that wound VOCs may have the potential to differentiate between healing and non-healing wounds. This study will use pilonidal abscesses for the analysis of wound VOC profiles using a non-invasive technique.

Conditions

Pilonidal Abscess; Non-healing Wound

Outcome Measures

Primary Outcomes (1)

• Volatile Organic Compound detection

  Feasibility of detecting VOC from pilonidal wound dressings as determined by mass-spec

  12 months

Study Arms (1)

Patients with Pilonidal Abcess

All adult (18+) patients presenting at surgical assessment unit requiring treatment for pilonidal abscess. Wounds will be drained, cleaned and packed as per usual clinical practice. Extra standard wound swabs will be collected for additional microbiological analyses. Control wound dressings will be placed on adjacent, unaffected area of skin for 24 hours.

Procedure: Drainage and packing of pilonidal abscess

Interventions

Drainage and packing of pilonidal abscess PROCEDURE

Patients will be treated as per standard care, their wound drained, cleaned and packed. Microbiology swab samples will be obtained.

Patients with Pilonidal Abcess

Eligibility Criteria

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

Study Population

All patients due to undergo acute surgical treatment for pilonidal sinus disease will be invited to participate in this study. A total of 12 patients will be recruited.

You may qualify if:

• Undergoing surgery for acute pilonidal abscess
• Aged 18 or over and able to give informed consent

You may not qualify if:

• Patients who are unwilling or unable to provide informed consent
• Patients who are unable to speak adequate English for informed consent

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead
• Cardiff Metropolitan University: collaborator

Study Sites (1)

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

Location

MeSH Terms

Interventions

Drainage

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 13, 2021
• Study Start: January 19, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 5, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)