A Comparative Study of the Efficacy and Safety of Two Methods in the Treatment of Skin Wounds

NCT07323615 | Not Yet Recruiting DMC

• 1 other identifier: Shanghai1st-SGu-1
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will compare the experimental group (debridement assisted by surgical microscope + VSD) and the control group (debridement under naked-eye observation + VSD) in terms of the rate of change in BWAT scores at one week postoperatively when the VSD is removed, daily wound negative-pressure drainage volume and pain scores within the first postoperative week, and results of two wound bacterial cultures. The study aims to scientifically evaluate the difference in efficacy between microscope-assisted debridement and naked-eye debridement, with the goal of providing a reference for the clinical debridement treatment of skin wounds.

Conditions

Wound Debridement

Keywords

skin wound; infection; debridement; microscope; therapeutic effect

Outcome Measures

Primary Outcomes (1)

• To compare the rate of change in wound scores between two methods of skin wound debridement.

  the rate of change in wound scores= (BWAT score at 1-week post-debridement (VSD removal) - Pre-debridement BWAT score) / Pre-debridement BWAT score. The Bates-Jensen Wound Assessment Tool (BWAT) is a comprehensive, standardized instrument designed for the detailed assessment and documentation of wound characteristics. It is widely used by healthcare professionals, particularly in wound care, dermatology, and long-term care settings, to evaluate a variety of chronic wounds, including pressure injuries, venous stasis ulcers, diabetic foot ulcers, and surgical wounds. The strength of the BWAT lies in its structured approach. It assesses 13 key wound characteristics, each characteristic is scored from 1-5. The HIGHER the total score(13-65), the more severe the wound status.

  one week

Secondary Outcomes (4)

• To compare the daily volume of wound negative pressure drainage between the two groups within one week postoperatively

  one week

• To compare the daily pain scores of patients between the two groups within one week postoperatively

  one week

• To compare the rate of conversion from positive to negative in wound bacterial culture between the two groups at one week postoperatively

  two weeks

• To compare the length of hospital stay between the two groups

  through study completion, an average of 1 month

Study Arms (2)

naked-eye

NO INTERVENTION

Debridement under naked-eye observation plus Vacuum Sealing Drainage (VSD)

microscopic

EXPERIMENTAL

Debridement under microscopic magnification assistance plus Vacuum Sealing Drainage (VSD).

Device: microscopic

Interventions

microscopic DEVICE

debridement with surgical microscope

microscopic

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged ≥18 years
• Patients with chronic skin wounds requiring surgical debridement due to causes such as trauma, diabetes, venous ulcers, or pressure injuries
• Patients whose systemic underlying medical conditions permit surgical tolerance
• Patients who agree to participate in the clinical study and provide signed informed consent

You may not qualify if:

• Presence of severe systemic immune diseases
• Known allergy to any component of the Vacuum Sealing Drainage (VSD) dressing
• Wounds with uncontrollable active major hemorrhage
• Visible bone fragments or internal fixation materials within the wound
• Pregnancy or lactation
• Inability to cooperate with or complete follow-up

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Infections

Central Study Contacts

Gu Song

CONTACT

China: 86+02137798561; Songgu2022@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director for Administration, Trauma Center

Model Details: Debridement under microscopic magnification assistance plus Vacuum Sealing Drainage (VSD).

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 7, 2026
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Sharing will begin within 6 months after the publication of the main study results in a peer-reviewed journal, last for 5 years.
• Access Criteria: Data will be made available to qualified researchers whose study proposals have been approved by an independent Data Access Committee for the purpose of independent verification or secondary meta-analysis.