Development of a Core Outcomes Set for Surgical Wounds Healing by Secondary Intention

Wounds created during a surgical procedure may be closed either primarily at the end of the operation with sutures or staples, or they may be managed by secondary intention. Management by secondary intention allows the wound to heal from the base up. Surgical wounds healing by secondary intention (SWHSI) are often managed in the community, and differ from chronic wounds in their acuity and their aetiology.

SWHSI are most commonly seen in infected wounds, and can lead to high levels of morbidity, resource-intensive care requirements and extensive effects on patients’ quality of life. Clinical trials that aim to improve the outcomes for people with SWHSI span interventions in dressings, topical medications, antibiotics, medical devices and service-based therapies. However, trials are often expensive to plan and run, they often have difficulty recruiting enough participants and they are frequently designed in isolation, meaning that their findings are difficult to combine or compare with other studies. Additionally, when patients with a SWHSI are seen in the outpatient department, GP practice or on the hospital ward, we do not have evidence-based outcome measures available to us to understand the impact of these wounds, interventions and services on the SWHSI population.

This study intends to use an established and validated methodology to produce a consensus core outcome set (COS) for use in research and clinical settings in the SWHSI population. This would provide utility by defining a minimum set of essential outcomes available for inclusion in all subsequent studies and clinical service evaluations, allowing for unfettered comparison between studies, straightforward combination of data for meta-analysis and optimisation of value from collected data.

Aim

To develop a Core Outcome Set for Surgical Wounds Healing by Secondary Intention

Contributors

Principal Investigator:
Dr Misha Sidapra

Supervisors:
Professor Ian Chetter

Professor Paul Tiffin

Ms Catherine Arundel

Further Study Information

Current Stage: Ongoing
Date: March 2023 - March 2026
Funding source(s): Misha Sidapra (Doctoral Research Fellow,?NIHR303688) is funded by the NIHR?for this research project. Dr Sidapra has also previously received funding from Hull University Teaching Hospitals NHS Trust Clinical Research Fellowship for preliminary contributing work.


Health Area

Disease Category: Wounds

Disease Name: Surgical wounds healing by secondary intention

Target Population

Age Range: 18

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Charities
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Device manufacturers
- Families
- Patient/ support group representatives
- Researchers
- Service commissioners
- Service providers
- Service users

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process
- Systematic review

1. Systematic review of published outcomes in specified population
2. Outcomes used in clinical practice - a survey of relevant clinical experts
3. Focus group studies with patient and carer stakeholder groups
4. Delphi prioritisation survey
5. Steering group consensus meeting