Use of White Granulated Sugar on Wounds
A Randomised Controlled Trial to Investigate the Clinical and Cost-effectiveness of White Granulated Sugar Dressing Compared With Standard Treatment in the Management of Exudating Wounds With Parallel Economic Evaluation
1 other identifier
interventional
108
1 country
1
Brief Summary
How effective is sugar in reducing the debriding of sloughy, necrotic or infected exudating wounds compared with standard treatment?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 24, 2012
CompletedFirst Posted
Study publicly available on registry
October 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedOctober 29, 2012
October 1, 2012
2.3 years
October 24, 2012
October 26, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Time to debridement of wound
wounds will be photographed at entry into the study there after weekly till end of study at 4 weeks
4 weeks
Secondary Outcomes (1)
Reduction in wound surface area
4 weeks
Other Outcomes (1)
Quality of life
4 weeks
Study Arms (2)
Chronic & Acute infected wounds
EXPERIMENTALWound will be cleaned with normal saline or tap water and Granulated sugar will be applied directly to the wound and covered with an absorbent pad and held in place with a bandage and tape.
Chronic and Acute infected wounds
ACTIVE COMPARATORWound will be cleaned with normal saline or tap water and an appropriate debridement dressing (Aquacel or Sorbsan) is applied to the wound and secured with a bandage and surgical tape.
Interventions
30 grams of granulated sugar is used to cover the wound area and this is held in place using a dry dressing pad , bandage and tape.
1 Aquacel or Sorbsan dressing will be put over the wound, and held in place with a dry dressing pad, bandage and tape.
Eligibility Criteria
You may qualify if:
- Exudating wound sizes 5cm2 and 40cm2
- A minimum of 25% slough, infected and necrotic tissue
- No dry necrotic eschar
- Ankle Brachial Pressure Index of greater than 0.6
- Age over 18 years
- Able to independently and willingly consent
You may not qualify if:
- Participants in a trial evaluating other therapies for their wound
- Have previously been in this trial
- Women who are pregnant
- Participants not able to tolerate daily dressing change
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Moses Murandulead
- Laboratoires URGOcollaborator
- University of Wolverhamptoncollaborator
- University of Birminghamcollaborator
Study Sites (1)
University Hospital Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2TH, United Kingdom
Related Publications (1)
Murandu M, Webber MA, Simms MH, Dealey C. Use of granulated sugar therapy in the management of sloughy or necrotic wounds: a pilot study. J Wound Care. 2011 May;20(5):206, 208, 210 passim. doi: 10.12968/jowc.2011.20.5.206.
PMID: 21647066BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Malcolm Simms, MBBSFRCS
University Hospital Birmingham NHS Fondation Trust
- STUDY DIRECTOR
Moses Murandu, PhD student
University of Wolverhampton
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PhD student
Study Record Dates
First Submitted
October 24, 2012
First Posted
October 29, 2012
Study Start
June 1, 2011
Primary Completion
October 1, 2013
Study Completion
October 1, 2014
Last Updated
October 29, 2012
Record last verified: 2012-10