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Surgical wounds healing by secondary intention

Surgical Wounds Healing by Secondary Intention (SWHSI): a pilot randomised controlled trial comparing negative pressure wound therapy and usual care for surgical wounds healing by secondary intention

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12761776
Enrollment
50
Registered
2015-12-10
Start date
2015-11-24
Completion date
Unknown
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Surgery

Interventions

Participants are randomly allocated to one of two groups. Group 1: Participants are treated using negative pressure wound therapy (NPWT). This is a vacuum pump which applies gentle suction to a wound

Sponsors

Hull and East Yorkshire Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or over 2. Receiving care from either within Hull and East Yorkshire, Leeds Teaching Hospitals or from Leeds Community Healthcare NHS Trusts 3. Surgical Wounds Healing by Secondary Intention (SWHSI) who could reasonably be treated with either NPWT (Negative Pressure Wound Therapy) or wound dressings, where SWHSI is defined as an open surgical wound not healing by primary intention but from the 'bottom up' 4. The wound should be considered ready for NPWT treatment (i.e. Contain at least 80% viable tissue or have only a very thin layer of slough requiring no further debridement) 5. The patient should be receiving adequate nutrition, as assessed by the senior nurse responsible for nursing care 6. Patients who are able to give informed consent

Exclusion criteria

Exclusion criteria: 1. Inability to provide informed consent 2. People with very limited life expectancy e.g. undergoing end stage palliative care 3. Active systemic infection at baseline, defined by clinical and/or laboratory assessment 4. People already receiving Negative Pressure Wound Therapy (NPWT) (or who have received NPWT on their current surgical wound healing by secondary intention (SWHSI)) 5. People who have received NPWT whilst in theatre for the surgery relating to their SWHSI 6. People without adequate haemostasis and who are at risk of bleeding 7. People with the following wound characteristics: 7.1. Presence of unclear undermining in the wound cavity, precluding the use of topical negative pressure therapy (i.e., the deepest point of the wound cannot be measured) 7.2. Necrotic tissue and/or eschar present 7.3. Malignant tissue in the wound 7.4. Wounds involving exposed blood vessels and/or organs, anastomotic sites and/or nerves (including the "open abdomen" where the abdominal fascia is open) 7.5. Wounds situated where, in the opinion of the treating clinician, a vacuum seal cannot be obtained 7.6. Chronic wounds such as pressure ulcers or foot ulcers that were non surgical in origin but which have been surgically debrided (we regard these as a very different subgroup) 7.7. People who are unwilling to have photographs taken of their wound 7.8. People who are currently participating in another research study or who have participated within the last 4 weeks

Design outcomes

Primary

MeasureTime frame
Time to healing is assessed by clinical assessment of the wound on a weekly basis with date of healing recorded when clinical assessment is that the wound has full epithelialisation and wound healing treatments have ceased.

Secondary

MeasureTime frame
Assessment of data collection methods for a larger study are assessed on an ongoing basis throughout the study duration.

Countries

England, United Kingdom

Contacts

Public ContactCatherine Arundel

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 11, 2026