Use of White Granulated Sugar on Wounds

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University Hospital Birmingham
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014