search
Back to results

Use of White Granulated Sugar on Wounds

Primary Purpose

Infected Wounds

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Granulated Sugar
Debridement Dressing
Sponsored by
Moses Murandu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infected Wounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Birmingham NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chronic & Acute infected wounds

Chronic and Acute infected wounds

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time to debridement of wound
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
Wound measurements will be taken at entry into the study then weekly until end of 4 weeks

Full Information

First Posted
October 24, 2012
Last Updated
October 26, 2012
Sponsor
Moses Murandu
Collaborators
Laboratoires URGO, University of Wolverhampton, University of Birmingham
search

1. Study Identification

Unique Protocol Identification Number
NCT01716273
Brief Title
Use of White Granulated Sugar on Wounds
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Moses Murandu
Collaborators
Laboratoires URGO, University of Wolverhampton, University of Birmingham

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infected Wounds

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chronic & Acute infected wounds
Arm Type
Experimental
Arm Description
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.
Arm Title
Chronic and Acute infected wounds
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Granulated Sugar
Other Intervention Name(s)
Sucrose
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Debridement Dressing
Other Intervention Name(s)
Aquacel or Sorbsan
Intervention Description
1 Aquacel or Sorbsan dressing will be put over the wound, and held in place with a dry dressing pad, bandage and tape.
Primary Outcome Measure Information:
Title
Time to debridement of wound
Description
wounds will be photographed at entry into the study there after weekly till end of study at 4 weeks
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Reduction in wound surface area
Description
Wound measurements will be taken at entry into the study then weekly until end of 4 weeks
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Quality of life
Description
Participants will be given a QOL questionnaire to complete before commencing the treatment and at the end of the 4 weeks
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moses Murandu, PhD student
Phone
07743025072
Email
mosesmurandu@wlv.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Malcolm Simms, MBBSFRCS
Phone
07768147025
Email
malcolm.simms@uhb.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm Simms, MBBSFRCS
Organizational Affiliation
University Hospital Birmingham NHS Fondation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Moses Murandu, PhD student
Organizational Affiliation
University of Wolverhampton
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Birmingham NHS Foundation Trust
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Hornabrook
Phone
0121 697 8311
Email
rachel.hornabrook@uhb.nhs.uk
First Name & Middle Initial & Last Name & Degree
Carol Dealey, PhD
Phone
0121 697 8311
Email
carol.dealey@uhb.nhs.uk
First Name & Middle Initial & Last Name & Degree
Moses Murandu, PhD student

12. IPD Sharing Statement

Citations:
PubMed Identifier
21647066
Citation
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.
Results Reference
background

Learn more about this trial

Use of White Granulated Sugar on Wounds

We'll reach out to this number within 24 hrs