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

Wound Infection Clinical Trial

Official title:

Ningbo NO.4 Hospital,CHINA.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02945761
• Other study ID #: wengxinhai
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 23, 2016
• Last updated: October 25, 2016
• Start date: October 2016

Study information

• Verified date: October 2016
• Source: Ningbo Municipal No.4 Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Zhejiang Province
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 100 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sugar Solution
• Wound Infection

Intervention

Procedure:
• High concentration of sugar solution

• conventional surgical dressing change

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ningbo Municipal No.4 Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes