NCT01716273

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 29, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 29, 2012

Status Verified

October 1, 2012

Enrollment Period

2.3 years

First QC Date

October 24, 2012

Last Update Submit

October 26, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Reduction in wound surface area

    4 weeks

Other Outcomes (1)

  • Quality of life

    4 weeks

Study Arms (2)

Chronic & Acute infected wounds

EXPERIMENTAL

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 SugarOther: Debridement Dressing

Chronic and Acute infected wounds

ACTIVE COMPARATOR

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 SugarOther: Debridement Dressing

Interventions

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.

Also known as: Sucrose
Chronic & Acute infected woundsChronic and Acute infected wounds

1 Aquacel or Sorbsan dressing will be put over the wound, and held in place with a dry dressing pad, bandage and tape.

Also known as: Aquacel or Sorbsan
Chronic & Acute infected woundsChronic and Acute infected wounds

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2TH, United Kingdom

RECRUITING

Related 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. doi: 10.12968/jowc.2011.20.5.206.

    PMID: 21647066BACKGROUND

MeSH Terms

Conditions

Wound Infection

Interventions

SucroseCarboxymethylcellulose Sodiumsorbsan

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsMethylcelluloseCelluloseGlucans

Study Officials

  • Malcolm Simms, MBBSFRCS

    University Hospital Birmingham NHS Fondation Trust

    PRINCIPAL INVESTIGATOR
  • Moses Murandu, PhD student

    University of Wolverhampton

    STUDY DIRECTOR

Central Study Contacts

Moses Murandu, PhD student

CONTACT

Malcolm Simms, MBBSFRCS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

October 24, 2012

First Posted

October 29, 2012

Study Start

June 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2014

Last Updated

October 29, 2012

Record last verified: 2012-10

Locations