Use of White Granulated Sugar on Wounds
This study is currently recruiting participants.
Verified October 2012 by University Hospital Birmingham
Sponsor:
Moses Murandu
Collaborators:
Laboratoires URGO
University of Wolverhampton
University of Birmingham
Information provided by (Responsible Party):
Moses Murandu, University Hospital Birmingham
ClinicalTrials.gov Identifier:
NCT01716273
First received: October 24, 2012
Last updated: October 26, 2012
Last verified: October 2012
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Purpose
How effective is sugar in reducing the debriding of sloughy, necrotic or infected exudating wounds compared with standard treatment?
| Condition | Intervention |
|---|---|
|
Infected Wounds |
Other: Granulated Sugar Other: Debridement Dressing |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by University Hospital Birmingham:
Primary Outcome Measures:
- Time to debridement of wound [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]wounds will be photographed at entry into the study there after weekly till end of study at 4 weeks
Secondary Outcome Measures:
- Reduction in wound surface area [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Wound measurements will be taken at entry into the study then weekly until end of 4 weeks
Other Outcome Measures:
- Quality of life [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Participants will be given a QOL questionnaire to complete before commencing the treatment and at the end of the 4 weeks
| Estimated Enrollment: | 108 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Chronic & Acute infected wounds
Wound 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.
|
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.
Other Name: Sucrose
Other: 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.
Other Name: Aquacel or Sorbsan
|
|
Active Comparator: Chronic and Acute infected wounds
Wound 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.
|
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.
Other Name: Sucrose
Other: 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.
Other Name: Aquacel or Sorbsan
|
Detailed 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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716273
Contacts
| Contact: Moses Murandu, PhD student | 07743025072 | mosesmurandu@wlv.ac.uk |
| Contact: Malcolm Simms, MBBSFRCS | 07768147025 | malcolm.simms@uhb.nhs.uk |
Locations
| United Kingdom | |
| University Hospital Birmingham NHS Foundation Trust | Recruiting |
| Birmingham, West Midlands, United Kingdom, B15 2TH | |
| Contact: Rachel Hornabrook 0121 697 8311 rachel.hornabrook@uhb.nhs.uk | |
| Contact: Carol Dealey, PhD 0121 697 8311 carol.dealey@uhb.nhs.uk | |
| Sub-Investigator: Moses Murandu, PhD student | |
Sponsors and Collaborators
Moses Murandu
Laboratoires URGO
University of Wolverhampton
University of Birmingham
Investigators
| Principal Investigator: | Malcolm Simms, MBBSFRCS | University Hospital Birmingham NHS Fondation Trust |
| Study Director: | Moses Murandu, PhD student | University of Wolverhampton |
More Information
Publications:
| Responsible Party: | Moses Murandu, PhD student, University Hospital Birmingham |
| ClinicalTrials.gov Identifier: | NCT01716273 History of Changes |
| Other Study ID Numbers: | RRK4106 |
| Study First Received: | October 24, 2012 |
| Last Updated: | October 26, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: National Health Service United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Wound Infection Infection Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013