Use of White Granulated Sugar on Wounds

Infected Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01716273
• Other study ID #: RRK4106
• Status: Recruiting
• Phase: N/A
• First received: October 24, 2012
• Last updated: October 26, 2012
• Start date: June 2011
• Est. completion date: October 2014

Study information

• Verified date: October 2012
• Source: University Hospital Birmingham
• Contact: Moses Murandu, PhD student
• Phone: 07743025072
• Email: mosesmurandu[@]wlv.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

How effective is sugar in reducing the debriding of sloughy, necrotic or infected exudating wounds compared with standard treatment?

Description:

Patients for whom all the following apply:

Have an exudating wound sizes 5cm2 and 40cm2 A minimum of 25% slough, infected and necrotic tissue No dry necrotic eschar present Ankle Brachial Pressure Index of greater than 0.6 Are over 18 years Independently and willingly consent

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: October 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infected Wounds
• Wound Infection

Intervention

Other:
• Granulated Sugar
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.
• Debridement Dressing
1 Aquacel or Sorbsan dressing will be put over the wound, and held in place with a dry dressing pad, bandage and tape.

Locations

Country	Name	City	State
United Kingdom	University Hospital Birmingham NHS Foundation Trust	Birmingham	West Midlands

Sponsors (4)

Lead Sponsor	Collaborator
Moses Murandu	Laboratoires URGO, University of Birmingham, University of Wolverhampton

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life	Participants will be given a QOL questionnaire to complete before commencing the treatment and at the end of the 4 weeks	4 weeks	No
Primary	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	No
Secondary	Reduction in wound surface area	Wound measurements will be taken at entry into the study then weekly until end of 4 weeks	4 weeks	No