Use of White Granulated Sugar on Wounds

October 26, 2012 updated by: Moses Murandu

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

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

Study Overview

Status

Unknown

Conditions

Intervention / 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

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • Recruiting
        • University Hospital Birmingham NHS Foundation Trust
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Moses Murandu, PhD student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Aquacel or Sorbsan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to debridement of wound
Time Frame: 4 weeks
wounds will be photographed at entry into the study there after weekly till end of study at 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in wound surface area
Time Frame: 4 weeks
Wound measurements will be taken at entry into the study then weekly until end of 4 weeks
4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 4 weeks
Participants will be given a QOL questionnaire to complete before commencing the treatment and at the end of the 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moses Murandu

Collaborators

University of Birmingham
Laboratoires URGO
University of Wolverhampton

Investigators

  • Principal Investigator: Malcolm Simms, MBBSFRCS, University Hospital Birmingham NHS Fondation Trust
  • Study Director: Moses Murandu, PhD student, University of Wolverhampton

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

October 24, 2012

First Submitted That Met QC Criteria

October 26, 2012

First Posted (Estimate)

October 29, 2012

Study Record Updates

Last Update Posted (Estimate)

October 29, 2012

Last Update Submitted That Met QC Criteria

October 26, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRK4106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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