Wound DebridementNCT07323615
A Comparative Study of the Efficacy and Safety of Two Methods in the Treatment of Skin Wounds
A study testing microscopic in people with Wound Debridement, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Wound Debridement
- What is being tested?
- microscopic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 16 Dec 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Center Randomized Controlled Trial Comparing the Efficacy and Safety of Naked-Eye Observation Versus Microscopic Magnification Observation in the Treatment of Skin Wounds
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.
Read the detailed description
Skin, which covers the body surface, is the outermost and largest organ of the human body. It is highly susceptible to various types of injuries, leading to acute or chronic wounds. Acute wounds typically result from sudden trauma, such as abrasions, friction injuries, cuts, or punctures, and are relatively easier to treat. Chronic wounds, on the other hand, refer to wounds that fail to achieve anatomical and functional integrity within the expected timeframe despite standardized and systematic treatment. Their pathogenesis is complex and often closely associated with multiple pathological factors such as infection, diabetic peripheral neuropathy and ischemic changes, persistent inflammatory responses, venous insufficiency, pressure injuries, and radiation damage. Such wounds are not only prolonged and recurrent, significantly impairing patients' quality of life, but also pose a major clinical challenge due to their difficulty in treatment and slow healing.
For skin wounds, the treatment principle is to perform thorough debridement first, followed by reconstructive surgery to cover the wound once infection is effectively controlled. Debridement is the core step in wound management, and its thoroughness directly impacts infection control, granulation tissue growth, and the final healing outcome. The 2023 Guidelines for the Diagnosis and Treatment of Chronic Refractory Wounds in Traumatic Orthopedics: Treatment Summary states that debridement, as the critical initial step in wound treatment, aims to remove necrotic tissue, reduce bioburden, control infection, and create favorable conditions for healing. The guidelines particularly emphasize adherence to the principle of "moderate debridement" , which involves thoroughly removing nonviable and heavily contaminated tissue while preserving as much viable tissue as possible to balance the completeness of wound bed preparation with the need for tissue preservation. Traditional debridement primarily relies on the surgeon's naked-eye observation and experience, which may fail to fully identify and remove all necrotic/infected tissue, micro-foreign bodies, and biofilms, or may lead to excessive debridement causing damage to healthy tissue. Both scenarios can impair wound bed preparation and ultimately affect the outcome of reconstructive surgery.
The surgical microscope is a commonly used device in trauma orthopedics and microsurgery, providing the surgeon with magnified, three-dimensional, and well-illuminated visual fields, mainly for the suturing and repair of delicate structures such as blood vessels and nerves. To date, there have been few reports on the use of surgical microscopes for skin wound debridement. Theoretically, with the aid of a microscope, clinicians could further enhance the discrimination between viable and necrotic tissue, achieving more precise and thorough debridement.
VSD (Vacuum Sealing Drainage) technology is an efficient drainage method that utilizes VSD materials and a semi-permeable membrane to isolate the wound from the external environment and promotes healing through continuous negative-pressure suction. The technique was first introduced by Dr. Fleischmann at Ulm University in Germany in 1992 and was introduced to China in 1994. The VSD negative-pressure closed drainage system consists of VSD material, a semi-permeable membrane, a three-way connector, and a negative-pressure suction device. It has been widely used in the treatment of skin wounds and can significantly improve local blood flow, reduce tissue edema, inhibit bacterial proliferation, and promote granulation tissue growth. Generally, one closed drainage session can maintain effective drainage for 5-7 days without requiring daily dressing changes.
The Bates-Jensen Wound Assessment Tool (BWAT) was developed by Bates-Jensen et al. in 1990 and revised in 2001. The revised BWAT includes two non-scored items (wound location and shape) and 13 scored items (size, depth, edges, undermining, necrotic tissue type and amount, exudate type and amount, periwound skin color, peripheral tissue edema and induration, granulation tissue, and epithelialization). The total score is the sum of the 13 item scores, with higher scores indicating more severe wound conditions. The validity and advantages of simplicity and speed of the BWAT have been confirmed in multiple clinical studies, providing objective and reliable data for assessing wound healing progress. Karahan tested the reliability and validity of the Turkish version of the BWAT, showing a content validity of 0.82 and a Cronbach's α coefficient of 0.85.
The surgical microscope offers advantages such as low cost, ease of operation, and integration into existing surgical workflows. A key foundation for the smooth implementation of this study is the full availability and routine use of internationally standardized, high-precision surgical microscope systems in the operating rooms of our hospital. This equipment is not temporarily acquired or specially introduced for this study but is an integral part of the standard operating room setup. Its performance parameters have been strictly calibrated and are maintained daily, fully meeting the technical requirements set by this study protocol. The devices are in good condition, regularly serviced and optically calibrated by professional engineers to ensure optimal imaging quality. Their stable yet flexible mounting systems accommodate different surgical positions and operator preferences. The surgical team is highly proficient in their operation, greatly facilitating the immediate initiation and efficient execution of the study protocol, thereby providing a solid guarantee for obtaining high-quality data within the planned timeframe.
- Conditions
- Wound Debridement
- Being tested
- microscopic
- Keywords
- skin wound, infection, debridement, microscope, therapeutic effect
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microscopicDevice
debridement with surgical microscope
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: microscopic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week
Secondary outcomes (4)
To compare the daily volume of wound negative pressure drainage between the two groups within one week postoperatively
Measure the volume of wound negative pressure drainage between the two groups everyday within one week postoperatively
Measured: one week
To compare the daily pain scores of patients between the two groups within one week postoperatively
The Visual Analogue Scale (VAS) was used to record pain scores.
Measured: one week
To compare the rate of conversion from positive to negative in wound bacterial culture between the two groups at one week postoperatively
Wound secretion bacterial cultures were performed both before and after the debridement procedure, each of which required approximately one week to obtain the results (positive or negative).
Measured: two weeks
To compare the length of hospital stay between the two groups
The total number of days from hospital admission to discharge was calculated.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start16 Dec 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound DebridementStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Debridement under microscopic magnification assistance plus Vacuum Sealing Drainage (VSD).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Gu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323615
- Sponsor's protocol ID
- Shanghai1st-SGu-1
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: individual participant data, as well as the study protocol, statistical analysis plan, and clinical study report.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Randomized Controlled Trial Comparing the Efficacy and Safety of Naked-Eye Observation Versus Microscopic Magnification Observation in the Treatment of Skin Wounds
- ClinicalTrials.gov ID
- NCT07323615
- Acronym / sponsor ID
- Shanghai1st-SGu-1
- Conditions
- Wound Debridement
- Keywords
- skin wound, infection, debridement, microscope, therapeutic effect
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 16 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Skin, which covers the body surface, is the outermost and largest organ of the human body. It is highly susceptible to various types of injuries, leading to acute or chronic wounds. Acute wounds typically result from sudden trauma, such as abrasions, friction injuries, cuts, or punctures, and are relatively easier to treat. Chronic wounds, on the other hand, refer to wounds that fail to achieve anatomical and functional integrity within the expected timeframe despite standardized and systematic treatment. Their pathogenesis is complex and often closely associated with multiple pathological factors such as infection, diabetic peripheral neuropathy and ischemic changes, persistent inflammatory responses, venous insufficiency, pressure injuries, and radiation damage. Such wounds are not only prolonged and recurrent, significantly impairing patients' quality of life, but also pose a major clinical challenge due to their difficulty in treatment and slow healing.
For skin wounds, the treatment principle is to perform thorough debridement first, followed by reconstructive surgery to cover the wound once infection is effectively controlled. Debridement is the core step in wound management, and its thoroughness directly impacts infection control, granulation tissue growth, and the final healing outcome. The 2023 Guidelines for the Diagnosis and Treatment of Chronic Refractory Wounds in Traumatic Orthopedics: Treatment Summary states that debridement, as the critical initial step in wound treatment, aims to remove necrotic tissue, reduce bioburden, control infection, and create favorable conditions for healing. The guidelines particularly emphasize adherence to the principle of "moderate debridement" , which involves thoroughly removing nonviable and heavily contaminated tissue while preserving as much viable tissue as possible to balance the completeness of wound bed preparation with the need for tissue preservation. Traditional debridement primarily relies on the surgeon's naked-eye observation and experience, which may fail to fully identify and remove all necrotic/infected tissue, micro-foreign bodies, and biofilms, or may lead to excessive debridement causing damage to healthy tissue. Both scenarios can impair wound bed preparation and ultimately affect the outcome of reconstructive surgery.
The surgical microscope is a commonly used device in trauma orthopedics and microsurgery, providing the surgeon with magnified, three-dimensional, and well-illuminated visual fields, mainly for the suturing and repair of delicate structures such as blood vessels and nerves. To date, there have been few reports on the use of surgical microscopes for skin wound debridement. Theoretically, with the aid of a microscope, clinicians could further enhance the discrimination between viable and necrotic tissue, achieving more precise and thorough debridement.
VSD (Vacuum Sealing Drainage) technology is an efficient drainage method that utilizes VSD materials and a semi-permeable membrane to isolate the wound from the external environment and promotes healing through continuous negative-pressure suction. The technique was first introduced by Dr. Fleischmann at Ulm University in Germany in 1992 and was introduced to China in 1994. The VSD negative-pressure closed drainage system consists of VSD material, a semi-permeable membrane, a three-way connector, and a negative-pressure suction device. It has been widely used in the treatment of skin wounds and can significantly improve local blood flow, reduce tissue edema, inhibit bacterial proliferation, and promote granulation tissue growth. Generally, one closed drainage session can maintain effective drainage for 5-7 days without requiring daily dressing changes.
The Bates-Jensen Wound Assessment Tool (BWAT) was developed by Bates-Jensen et al. in 1990 and revised in 2001. The revised BWAT includes two non-scored items (wound location and shape) and 13 scored items (size, depth, edges, undermining, necrotic tissue type and amount, exudate type and amount, periwound skin color, peripheral tissue edema and induration, granulation tissue, and epithelialization). The total score is the sum of the 13 item scores, with higher scores indicating more severe wound conditions. The validity and advantages of simplicity and speed of the BWAT have been confirmed in multiple clinical studies, providing objective and reliable data for assessing wound healing progress. Karahan tested the reliability and validity of the Turkish version of the BWAT, showing a content validity of 0.82 and a Cronbach's α coefficient of 0.85.
The surgical microscope offers advantages such as low cost, ease of operation, and integration into existing surgical workflows. A key foundation for the smooth implementation of this study is the full availability and routine use of internationally standardized, high-precision surgical microscope systems in the operating rooms of our hospital. This equipment is not temporarily acquired or specially introduced for this study but is an integral part of the standard operating room setup. Its performance parameters have been strictly calibrated and are maintained daily, fully meeting the technical requirements set by this study protocol. The devices are in good condition, regularly serviced and optically calibrated by professional engineers to ensure optimal imaging quality. Their stable yet flexible mounting systems accommodate different surgical positions and operator preferences. The surgical team is highly proficient in their operation, greatly facilitating the immediate initiation and efficient execution of the study protocol, thereby providing a solid guarantee for obtaining high-quality data within the planned timeframe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Debridement under microscopic magnification assistance plus Vacuum Sealing Drainage (VSD).
| Arm | Type | Receives |
|---|---|---|
| naked-eye | No intervention | –Debridement under naked-eye observation plus Vacuum Sealing Drainage (VSD) |
| microscopic | Experimental | Device: microscopicDebridement under microscopic magnification assistance plus Vacuum Sealing Drainage (VSD). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microscopicdebridement with surgical microscope | Device | microscopic |
Primary outcome
To compare the rate of change in wound scores between two methods of skin wound debridement.
Time frame: one week
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.
4 secondary outcomes
To compare the daily volume of wound negative pressure drainage between the two groups within one week postoperatively
Time frame: one week
To compare the daily pain scores of patients between the two groups within one week postoperatively
Time frame: one week
To compare the rate of conversion from positive to negative in wound bacterial culture between the two groups at one week postoperatively
Time frame: two weeks
To compare the length of hospital stay between the two groups
Time frame: through study completion, an average of 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: Yes. individual participant data, as well as the study protocol, statistical analysis plan, and clinical study report.
Related trials for Wound Debridement
RecruitingPhase 3
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
Venous Leg Ulcer (VLU)
Recruiting
Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy
Chondral Lesion of the Knee, Meniscal Injuries
Recruiting
Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers
Diabetic Foot Ulcers (DFUs), Diabetic Foot
Recruiting
Inhalation Aromatherapy for Patients Undergoing Conservative Sharp Wound Debridement:
Aromatherapy
Not yet recruitingPhase 2
An Open Label, Single Treatment, Single Arm, Multiple Dose Phase-2 Study to Evaluate the Pharmacokinetics, Safety, and Clinical Performance of EscharEx (EX-03) in Participants With Venous Leg Ulcers
Venous Leg Ulcer (VLU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing microscopic in people with Wound Debridement, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gu Song (China: 86+02137798561, Songgu2022@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the rate of change in wound scores between two methods of skin wound debridement. (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.