Wound InfectionNCT02945761
High Concentration of Sugar Solution Irrigation Promotes the Healing of Infected Wound
A study testing High concentration of sugar solution and conventional surgical dressing change in people with Wound Infection and Sugar Solution, run by Ningbo Municipal No.4 Hospital.
Trial summary
Surgeons easily get wound infections. Most wound infections will be cured by applying medicines and changing dressing in very short period of time. But some wounds are severely contaminated combined with fat liquefaction, crateriform ulcer and large undermined lacuna, so changing dressing takes a very long time. Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- Wound Infection, Sugar Solution
- What is being tested?
- High concentration of sugar solution and conventional surgical dressing change
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Oct 2017
- 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 1 year to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients conducted surgical operation in the hospital within 2 weeks. The wound had swelling and lots of secretions;
- Except for the incision, primary surgical site has been recovered smoothly. Patients didn't accept secondary operation in the same site;
Who cannot join
- 1. Except for the wound that can't use healthy skin closure in Phase I
About this study
Official title: Ningbo NO.4 Hospital,CHINA.
Surgeons easily get wound infections. Most wound infections will be cured by applying medicines and changing dressing in very short period of time. But some wounds are severely contaminated combined with fat liquefaction, crateriform ulcer and large undermined lacuna, so changing dressing takes a very long time. In order to better change the dressing, it needs to expose the wound thoroughly, which requires to completely open the healed skin, so the healing will be slowed down. Some scholars lay stress on prevention. Wound infection control concerns prevention--not therapy--of an infrequent but expensive kind of surgical morbidity.(1.2)Some scholars think that the main armamentarium of the attack is the use of topical anti-infectives, which invade the bacteria where they reside, and, consequently, reduce their numbers and promote wound healing.(3)For example, silver is reemerging as a viable treatment option for infections encountered in burns, open wounds, and chronic ulcers. But it is expensive and is difficult to acquire silver-containing dressings. And Recent findings, however, indicate that the compound delays the wound-healing process and that silver may have serious cytotoxic activity on various host cells. (4) As High concentration of sugar solution, honey appears to heal partial thickness burns more quickly than conventional treatment (which included polyurethane film, paraffin gauze, soframycin-impregnated gauze, sterile linen and leaving the burns exposed) and infected post-operative wounds more quickly than antiseptics and gauze.(5)This study involve the use of another high-concentration of sugar solution (HCSS) to lavage infected wounds when changing dressings.
- Conditions
- Wound Infection, Sugar Solution
- Being tested
- High concentration of sugar solution, conventional surgical dressing change
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High concentration of sugar solutionProcedure or surgery
conventional surgical dressing changeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| High concentration of sugar solution | Active comparator | Lavage group of high-concentration sugar solution (HCSS): disinfected the Skin outside wound with conventional PVP. HCSS refers to supersaturated sugar solution made of 50% high-concentration glucose and white sugar. Prior to wound irrigation, dry cotton balls are used to wipe the wound and internal lacuna, to clean some necrotic tissues out of the wound. HCSS is applied on the wound once a day, and whether the lavaging is stopped based on the amount of exudation from the wound. Receives: Procedure: High concentration of sugar solution |
| conventional surgical dressing change | Active comparator | conventional surgical dressing change:separated suture, expanded the wound, placed drainage ribbon gauze and used hydrogen peroxide or(and) PVP to wash the wound; the decision-making power of these operators is determined by a doctor. After the doctor confirms granulation cleaning in the wound, the decision-making power of suture is also determined by a doctor. Receives: Procedure: conventional surgical dressing change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of wound healing
It means the time from the first day after incision infection is found out to continuous dressing change in the last time. If the wound is kept in the infection status, it requires changing it for the wound once a day. For phase II suture on the open incision, the last time of dressing change should add the following days. Abdominal incision should increase 5 days. The wound of four limbs should increase 10 days.
Measured: 4 weeks
The scoring on the open wound
Without separating suture, only the wound is shoved off within 2cm for 1 score; with separating suture, but the distance is kept in 2cm for 2 scores; with separating suture, the wound is shoved off for 2-3cm for 3 scores; In a similar fashion, the highest one is 10 scores. For patients with the longer wound and disconnected openness, the overall length of the wound should be overlapped. According to the overall length, scores are conducted as the above-mentioned rules.
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 posted26 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound InfectionStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo Municipal No.4 Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, weng xinhai, Ningbo Municipal No.4 Hospital
- Investigators
- xinhai weng, BS, Study director, Ningbo NO.4 hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945761
- Sponsor's protocol ID
- wengxinhai
- Status last verified
- Oct 2016
- First submitted
- 23 Oct 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ningbo NO.4 Hospital,CHINA.
- ClinicalTrials.gov ID
- NCT02945761
- Acronym / sponsor ID
- wengxinhai
- Conditions
- Wound Infection, Sugar Solution
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Ningbo Municipal No.4 HospitalOther government
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- First posted
- 26 Oct 2016 (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.
Surgeons easily get wound infections. Most wound infections will be cured by applying medicines and changing dressing in very short period of time. But some wounds are severely contaminated combined with fat liquefaction, crateriform ulcer and large undermined lacuna, so changing dressing takes a very long time. In order to better change the dressing, it needs to expose the wound thoroughly, which requires to completely open the healed skin, so the healing will be slowed down. Some scholars lay stress on prevention. Wound infection control concerns prevention--not therapy--of an infrequent but expensive kind of surgical morbidity.(1.2)Some scholars think that the main armamentarium of the attack is the use of topical anti-infectives, which invade the bacteria where they reside, and, consequently, reduce their numbers and promote wound healing.(3)For example, silver is reemerging as a viable treatment option for infections encountered in burns, open wounds, and chronic ulcers. But it is expensive and is difficult to acquire silver-containing dressings. And Recent findings, however, indicate that the compound delays the wound-healing process and that silver may have serious cytotoxic activity on various host cells. (4) As High concentration of sugar solution, honey appears to heal partial thickness burns more quickly than conventional treatment (which included polyurethane film, paraffin gauze, soframycin-impregnated gauze, sterile linen and leaving the burns exposed) and infected post-operative wounds more quickly than antiseptics and gauze.(5)This study involve the use of another high-concentration of sugar solution (HCSS) to lavage infected wounds when changing dressings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High concentration of sugar solution | Active comparator | Procedure: High concentration of sugar solutionLavage group of high-concentration sugar solution (HCSS): disinfected the Skin outside wound with conventional PVP. HCSS refers to supersaturated sugar solution made of 50% high-concentration glucose and white sugar. Prior to wound irrigation, dry cotton balls are used to wipe the wound and internal lacuna, to clean some necrotic tissues out of the wound. HCSS is applied on the wound once a day, and whether the lavaging is stopped based on the amount of exudation from the wound. |
| conventional surgical dressing change | Active comparator | Procedure: conventional surgical dressing changeconventional surgical dressing change:separated suture, expanded the wound, placed drainage ribbon gauze and used hydrogen peroxide or(and) PVP to wash the wound; the decision-making power of these operators is determined by a doctor. After the doctor confirms granulation cleaning in the wound, the decision-making power of suture is also determined by a doctor. |
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients conducted surgical operation in the hospital within 2 weeks. The wound had swelling and lots of secretions;
- Except for the incision, primary surgical site has been recovered smoothly. Patients didn't accept secondary operation in the same site;
Key exclusion criteria (1 listed)
- 1. Except for the wound that can't use healthy skin closure in Phase I
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 |
|---|---|---|
| High concentration of sugar solution | Procedure or surgery | High concentration of sugar solution |
| conventional surgical dressing change | Procedure or surgery | conventional surgical dressing change |
Primary outcome
Duration of wound healing
Time frame: 4 weeks
It means the time from the first day after incision infection is found out to continuous dressing change in the last time. If the wound is kept in the infection status, it requires changing it for the wound once a day. For phase II suture on the open incision, the last time of dressing change should add the following days. Abdominal incision should increase 5 days. The wound of four limbs should increase 10 days.
The scoring on the open wound
Time frame: 4 weeks
Without separating suture, only the wound is shoved off within 2cm for 1 score; with separating suture, but the distance is kept in 2cm for 2 scores; with separating suture, the wound is shoved off for 2-3cm for 3 scores; In a similar fashion, the highest one is 10 scores. For patients with the longer wound and disconnected openness, the overall length of the wound should be overlapped. According to the overall length, scores are conducted as the above-mentioned rules.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
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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.
xinhai weng, BS study director
Ningbo NO.4 hospital
Questions about this trial
What is this clinical trial studying?
A study testing High concentration of sugar solution and conventional surgical dressing change in people with Wound Infection and Sugar Solution, run by Ningbo Municipal No.4 Hospital.
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 2 inclusion and 1 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 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of wound healing (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2016.