Surgical wounds healing by secondary intentio

Not Applicable

Completed

• Conditions: Topic: Surgery; Subtopic: Surgery; Disease: All Surgery; Skin and Connective Tissue Diseases; Surgical wound healing

• Registration Number: ISRCTN12761776
• Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust

Brief Summary

2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/27821142 protocol 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29951633 results (added 29/01/2019) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32888791/ feedback from research nurses (added 08/09/2020) 2020 Funder report results in https://doi.org/10.3310/pgfar08070 (added 04/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-10
• Study Completion: 2016-05-31
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified