NCT02945761

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.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

October 23, 2016

Last Update Submit

October 25, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    4 weeks

Study Arms (2)

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.

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.

Procedure: conventional surgical dressing change

Interventions

High concentration of sugar solution
conventional surgical dressing change

Eligibility Criteria

Age1 Year - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • \. Except for the wound that can't use healthy skin closure in Phase I

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • xinhai weng, BS

    Ningbo NO.4 hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 23, 2016

First Posted

October 26, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2017

Last Updated

October 26, 2016

Record last verified: 2016-10