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High Concentration of Sugar Solution Irrigation Promotes the Healing of Infected Wound

Primary Purpose

Wound Infection, Sugar Solution

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High concentration of sugar solution
conventional surgical dressing change
Sponsored by
Ningbo Municipal No.4 Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Infection

Eligibility Criteria

1 Year - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients conducted surgical operation in the hospital within 2 weeks. The wound had swelling and lots of secretions;
  2. 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    High concentration of sugar solution

    conventional surgical dressing change

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 23, 2016
    Last Updated
    October 25, 2016
    Sponsor
    Ningbo Municipal No.4 Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02945761
    Brief Title
    High Concentration of Sugar Solution Irrigation Promotes the Healing of Infected Wound
    Official Title
    Ningbo NO.4 Hospital,CHINA.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    October 2017 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ningbo Municipal No.4 Hospital

    4. Oversight

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wound Infection, Sugar Solution

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    3 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High concentration of sugar solution
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    conventional surgical dressing change
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    High concentration of sugar solution
    Intervention Type
    Procedure
    Intervention Name(s)
    conventional surgical dressing change
    Primary Outcome Measure Information:
    Title
    Duration of wound healing
    Description
    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.
    Time Frame
    4 weeks
    Title
    The scoring on the open wound
    Description
    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.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    xinhai weng, BS
    Organizational Affiliation
    Ningbo NO.4 hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

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