Infected WoundsNCT01716273
Use of White Granulated Sugar on Wounds
A study testing Granulated Sugar and Debridement Dressing in people with Infected Wounds, run by Moses Murandu at 1 site in United Kingdom.
Trial summary
How effective is sugar in reducing the debriding of sloughy, necrotic or infected exudating wounds compared with standard treatment? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infected Wounds
- What is being tested?
- Granulated Sugar and Debridement Dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2TH
Rachel Hornabrook, 0121 697 8311, rachel.hornabrook@uhb.nhs.uk
Carol Dealey, PhD, 0121 697 8311, carol.dealey@uhb.nhs.uk
About this study
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
How effective is sugar in reducing the debriding of sloughy, necrotic or infected exudating wounds compared with standard treatment?
Read the 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
- Conditions
- Infected Wounds
- Being tested
- Granulated Sugar, Debridement Dressing
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulated SugarOther
Also called Sucrose
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.
Debridement DressingOther
Also called Aquacel or Sorbsan
1 Aquacel or Sorbsan dressing will be put over the wound, and held in place with a dry dressing pad, bandage and tape.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Granulated Sugar; Other: 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. Receives: Other: Granulated Sugar; Other: Debridement Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to debridement of wound
wounds will be photographed at entry into the study there after weekly till end of study at 4 weeks
Measured: 4 weeks
Secondary outcomes (1)
Reduction in wound surface area
Wound measurements will be taken at entry into the study then weekly until end of 4 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startJun 2011
- Primary completionOct 2013 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infected WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moses Murandu
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoires URGO, University of Wolverhampton, University of Birmingham
- Responsible party
- Sponsor-investigator, Moses Murandu, University Hospital Birmingham
- Investigators
- Malcolm Simms, MBBSFRCS, Principal investigator, University Hospital Birmingham NHS Fondation TrustMoses Murandu, PhD student, Study director, University of Wolverhampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716273
- Sponsor's protocol ID
- RRK4106
- Status last verified
- Oct 2012
- First submitted
- 24 Oct 2012
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21647066
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01716273
- Acronym / sponsor ID
- RRK4106
- Conditions
- Infected Wounds
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Moses MuranduUniversity, hospital or other
- Collaborators
- Laboratoires URGO, University of Wolverhampton, University of Birmingham
- Study start
- Jun 2011
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 29 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic & Acute infected wounds | Experimental | Other: Granulated Sugar, Other: Debridement DressingWound 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. |
| Chronic and Acute infected wounds | Active comparator | Other: Granulated Sugar, Other: Debridement DressingWound 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Granulated SugarAlso: Sucrose30 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 | Chronic & Acute infected wounds, Chronic and Acute infected wounds |
| Debridement DressingAlso: Aquacel or Sorbsan1 Aquacel or Sorbsan dressing will be put over the wound, and held in place with a dry dressing pad, bandage and tape. | Other | Chronic & Acute infected wounds, Chronic and Acute infected wounds |
Primary outcome
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
1 secondary outcome
Reduction in wound surface area
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2012.
- Background: PubMed 21647066Murandu 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.
Related trials for Infected Wounds
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Not yet recruitingPhase 3
Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation:
Next Generation Sequencing (NGS), Surgical Site Infection (SSI)
RecruitingPhase 4
Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive Surgery
Surgical Wound Infection, Neck Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm Simms, MBBSFRCS principal investigator
University Hospital Birmingham NHS Fondation Trust
Moses Murandu, PhD student study director
University of Wolverhampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Granulated Sugar and Debridement Dressing in people with Infected Wounds, run by Moses Murandu at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moses Murandu, PhD student (07743025072, mosesmurandu@wlv.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to debridement of wound (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01716273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2012.