Wound management of Open Lower Limb Fractures (WOLLF)

Not Applicable

Completed

• Conditions: Open fractures of the lower limb; Injury, Occupational Diseases, Poisoning; Fracture of lower limb, level unspecified

• Registration Number: ISRCTN33756652
• Lead Sponsor: niversity of Warwick (UK)

Brief Summary

2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26395498 2018 results in http://www.ncbi.nlm.nih.gov/pubmed/29896626 2018 qualitative study results in http://www.ncbi.nlm.nih.gov/pubmed/29941030 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30573002 2019 patient experience of recovery results in https://pubmed.ncbi.nlm.nih.gov/31601595/ (added 23/10/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-24
• Study Completion: 2017-03-01
• Last Update Posted: 2 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

1. Aged 16 years or older
2. Present to the trial hospital within 72 hours of injury
3. Have an open fracture of the lower limb - graded as Gustilo and Anderson 2 or 3.

Exclusion Criteria

1. There are contra-indications to anaesthesia such that the patient is unable to have surgery
2. There is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires, such as permanent cognitive impairment. It is expected that for a very small proportion of patients this exclusion criterion will only be determined after randomisation has taken place. These patients will then be excluded from the study and no patient identifiable data will be retained.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disability Rating Index (DRI) - a self administered, 12-item Visual Analogue Scale questionnaire assessing the patients' own rating of their disability. This measure was chosen as it addresses 'gross body movements' rather than specific joints or body segments. Therefore, it will facilitate the assessment of patients with different fractures of the lower limb. This data will be collected at baseline, 3, 6, 9 and 12 months post-operatively.