- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02945761
High Concentration of Sugar Solution Irrigation Promotes the Healing of Infected Wound
October 25, 2016 updated by: weng xinhai, Ningbo Municipal No.4 Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
3
Phase
- Not Applicable
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
1 year to 100 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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;
Exclusion Criteria:
1. Except for the wound that can't use healthy skin closure in Phase I
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: High concentration of sugar solution
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.
|
|
Active Comparator: conventional surgical dressing change
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 weeks
|
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.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: xinhai weng, BS, Ningbo NO.4 hospital
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
October 1, 2016
Primary Completion (Anticipated)
October 1, 2017
Study Registration Dates
First Submitted
October 23, 2016
First Submitted That Met QC Criteria
October 25, 2016
First Posted (Estimate)
October 26, 2016
Study Record Updates
Last Update Posted (Estimate)
October 26, 2016
Last Update Submitted That Met QC Criteria
October 25, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- wengxinhai
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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