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| Name | Class |
|---|---|
| thermofield | INDUSTRY |
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This study will include 20 healthy subjects with intact skin on their lower legs that meet inclusion criteria. Participants will serve as their own control, by heating one leg and not the other. The radiofrequency device consists of a 4 by 6 inch heating pad connected to a temperature controller. Subjects will receive weekly treatments for 4 weeks, and will be re-evaluated 4 weeks after the last treatment to assess any tissue changes that continue after the treatments have concluded.
This study will include 20 healthy subjects with intact skin on their lower legs that meet inclusion criteria below. Participants will serve as their own control, by heating one leg and not the other. The radiofrequency device consists of a 4 by 6 inch heating pad connected to a temperature controller. The pad will be applied to the back of the leg and will covered using a compression stocking. The other leg will receive a pad and compression stocking, but radiofrequency will not be applied (no heating).
At the first visit, subjects will be asked to fill out a healthcare questionnaire. With each weekly treatment, subjects will be evaluated to assess how their legs feel on a scale of 1-10, with 1 being no discomfort and 10 being intense pain. Their legs will be photographed before and after radiofrequency MH to examine any visible changes to the tissue. Study team will then use a PeriScan PIM 3 System Laser Doppler scanning for blood perfusion before the Thermofield treatment. The radiofrequency will be set to achieve 40°C/107.6°F) and maintain this temperature consistently during the application time. This temperature is mild and may feel like a drugstore heating pad. The device will be turned on on one leg and will remain off on the other. The time for the heating will be 36 minutes, during which participants will remain in a reclined position, with their legs elevated. The device takes approximately 6 minutes to achieve a tissue temperature of 40°C, and the treatment time with consistent temperature application will be 30 minutes. Study team will then use a PeriScan PIM 3 System Laser Doppler scanning for blood perfusion after the Thermofield treatment ends. Study team will take thermal imaging photographs of the treatment area following each treatment.
Subjects will receive weekly treatments for 4 weeks, and will be re-evaluated 4 weeks after the last treatment to assess any tissue changes that continue after the treatments have concluded. Subjects will be excluded from the study if they develop any kind of intolerance to the MH treatment, like increased pain or unexpected skin changes. If they receive a significant injury or wound that is not due to the study, such that the skin of the lower leg is no longer intact, they will be excluded from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermofield temperature controlled radiofrequency device | Experimental | Participants will serve as their own control, by heating one leg and not the other. The radiofrequency device consists of a 4 by 6 inch heating pad connected to a temperature controller. The pad will be applied to the back of the leg and will covered using a compression stocking. The other leg will receive a pad and compression stocking, but radiofrequency will not be applied (no heating). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Doppler | Device | Study team will use a PeriScan PIM 3 System Laser Doppler to scan for blood perfusion before and after the Thermofield treatment. The PeriScan PIM 3 System is for non-invasive two-dimensional imaging of peripheral tissue. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Temperature Change- Skin Evaluation on Leg With Device | To help determine safety during and after dermal application for generating elevated temperatures | week 1 |
| Mean Temperature Change- Skin Evaluation on Leg With Device | To help determine safety during and after dermal application for generating elevated temperatures | week 2 |
| Mean Temperature Change- Skin Evaluation on Leg With Device | To help determine safety during and after dermal application for generating elevated temperatures | week 3 |
| Mean Temperature Change- Skin Evaluation on Leg With Device | To help determine safety during and after dermal application for generating elevated temperatures | week 4 |
| Mean Change in Blood Perfusion Assessment - mL/kg/Min | Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied. Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min) | week 1 |
| Blood Perfusion Assessment - mL/kg/Min | Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied. Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Attended the Session | The number of participants who attend hyperthermia sessions will be documented. | week 1 |
| Number of Participants Who Attended the Session | The number of participants who attend hyperthermia sessions will be documented. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Levi, PhD | Atrium Health Wake Forest Baptist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Thermofield Temperature Controlled Radiofrequency Device | Participants will serve as their own control, by heating one leg and not the other. The radiofrequency device consists of a 4 by 6 inch heating pad connected to a temperature controller. The pad will be applied to the back of the leg and will covered using a compression stocking. The other leg will receive a pad and compression stocking, but radiofrequency will not be applied (no heating). Laser Doppler: Study team will use a PeriScan PIM 3 System Laser Doppler to scan for blood perfusion before and after the Thermofield treatment. The PeriScan PIM 3 System is for non-invasive two-dimensional imaging of peripheral tissue. Radiofrequency Heating System: The radiofrequency will be set to achieve 42°C/107.6°F) and maintain this temperature consistently during the application time. This temperature is mild and may feel like a drugstore heating pad. The device will be turned on on one leg and will remain off on the other. The time for the heating will be 36 minutes, during which participants will remain in a reclined position, with their legs elevated. The device takes approximately 6 minutes to achieve a tissue temperature of 42°C, and the treatment time with consistent temperature application will be 30 minutes. Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Thermofield Temperature Controlled Radiofrequency Device | Participants will serve as their own control, by heating one leg and not the other. The radiofrequency device consists of a 4 by 6 inch heating pad connected to a temperature controller. The pad will be applied to the back of the leg and will covered using a compression stocking. The other leg will receive a pad and compression stocking, but radiofrequency will not be applied (no heating). Laser Doppler: Study team will use a PeriScan PIM 3 System Laser Doppler to scan for blood perfusion before and after the Thermofield treatment. The PeriScan PIM 3 System is for non-invasive two-dimensional imaging of peripheral tissue. Radiofrequency Heating System: The radiofrequency will be set to achieve 42°C/107.6°F) and maintain this temperature consistently during the application time. This temperature is mild and may feel like a drugstore heating pad. The device will be turned on on one leg and will remain off on the other. The time for the heating will be 36 minutes, during which participants will remain in a reclined position, with their legs elevated. The device takes approximately 6 minutes to achieve a tissue temperature of 42°C, and the treatment time with consistent temperature application will be 30 minutes. Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Temperature Change- Skin Evaluation on Leg With Device | To help determine safety during and after dermal application for generating elevated temperatures | Posted | Mean | Standard Error | degrees | week 1 | Legs | Legs |
|
Adverse event data was collected throughout the life of the study (8 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Thermofield Temperature Controlled Radiofrequency Device | Participants will serve as their own control, by heating one leg and not the other. The radiofrequency device consists of a 4 by 6 inch heating pad connected to a temperature controller. The pad will be applied to the back of the leg and will covered using a compression stocking. The other leg will receive a pad and compression stocking, but radiofrequency will not be applied (no heating). Laser Doppler: Study team will use a PeriScan PIM 3 System Laser Doppler to scan for blood perfusion before and after the Thermofield treatment. The PeriScan PIM 3 System is for non-invasive two-dimensional imaging of peripheral tissue. Radiofrequency Heating System: The radiofrequency will be set to achieve 42°C/107.6°F) and maintain this temperature consistently during the application time. This temperature is mild and may feel like a drugstore heating pad. The device will be turned on on one leg and will remain off on the other. The time for the heating will be 36 minutes, during which participants will remain in a reclined position, with their legs elevated. The device takes approximately 6 minutes to achieve a tissue temperature of 42°C, and the treatment time with consistent temperature application will be 30 minutes. Thermal Imaging: Study team will take thermal imaging photographs of the treatment area following each treatment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burn/knot | Skin and subcutaneous tissue disorders | Systematic Assessment | 1 Subject experienced superficial burn and 2 others experienced a tender "knot" under the skin where the heating pad had been placed (L calf). All 3 Subjects were WD from the study and followed until healed. All 3 received therapeutic radiofrequency |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Levi | Atrium Health Wake Forest Baptist | 336-716-4171 | nlevi@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 5, 2021 | Feb 6, 2024 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 31, 2023 | Dec 19, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D017695 | Soft Tissue Injuries |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017078 | Laser-Doppler Flowmetry |
| D014894 | Weights and Measures |
| ID | Term |
|---|---|
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012212 | Rheology |
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20 healthy subjects with intact skin on their lower legs that meet inclusion criteria - Participants will serve as their own control, by heating one leg and no the other.
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| Radiofrequency Heating System | Device | The radiofrequency will be set to achieve 42°C/107.6°F) and maintain this temperature consistently during the application time. This temperature is mild and may feel like a drugstore heating pad. The device will be turned on on one leg and will remain off on the other. The time for the heating will be 36 minutes, during which participants will remain in a reclined position, with their legs elevated. The device takes approximately 6 minutes to achieve a tissue temperature of 42°C, and the treatment time with consistent temperature application will be 30 minutes. |
|
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| Thermal Imaging | Device | Study team will take thermal imaging photographs of the treatment area following each treatment. |
|
| Healthcare Questionnaire & Measurement | Other | A survey tool created to collect info from participants including:
A measurement of the participants calf will be taken as well using a measuring tape. |
|
| week 2 |
| Blood Perfusion Assessment - mL/kg/Min | Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied. Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min) | week 3 |
| Blood Perfusion Assessment - mL/kg/Min | Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied. Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min) | week 4 |
| Blood Perfusion Assessment - mL/kg/Min | Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied. Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min) | week 8 |
| Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment | A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used. | week 1 |
| Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment | A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used. | week 2 |
| Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment | A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used. | week 3 |
| Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment | A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used. | week 4 |
| Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment | A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used. | week 8 |
| Safety: Number of Blister Formations | Cumulative number of blisters formed across all participants during weekly sessions from week 1 to 8 is reported in the data table. | From week 1 through week 8 |
| Safety: Significant Changes in Redness | Number of participants with significant changes in redness that required intervention. | from week 1 through week 8 |
| week 2 |
| Number of Participants Who Attended the Session | The number of participants who attend hyperthermia sessions will be documented. | week 3 |
| Number of Participants Who Attended the Session | The number of participants who attend hyperthermia sessions will be documented. | week 4 |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Primary | Mean Temperature Change- Skin Evaluation on Leg With Device | To help determine safety during and after dermal application for generating elevated temperatures | Posted | Mean | Standard Error | Degrees | week 2 | legs | legs |
|
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| Primary | Mean Temperature Change- Skin Evaluation on Leg With Device | To help determine safety during and after dermal application for generating elevated temperatures | Subject 3 was withdrawn after treatment 2 because he developed a red spot and ultimately a small wound. Subject 9 and 10 were withdrawn after treatment 2 because they developed a lump under the skin. | Posted | Mean | Standard Error | degrees | week 3 | legs | legs |
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| Primary | Mean Temperature Change- Skin Evaluation on Leg With Device | To help determine safety during and after dermal application for generating elevated temperatures | Subject 3 was withdrawn after treatment 2 - Subjects 9 and 10 were withdrawn after treatment 2 - Subject 8 did not complete - Subject 20 temperature check was not measured | Posted | Mean | Standard Error | degrees | week 4 | legs | legs |
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| Primary | Mean Change in Blood Perfusion Assessment - mL/kg/Min | Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied. Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min) | change in pre and post perfusion for subjects at week 1 - Subject 3 was withdrawn | Posted | Mean | Standard Error | mL/kg/min | week 1 | legs | legs |
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| Primary | Blood Perfusion Assessment - mL/kg/Min | Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied. Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min) | change in pre and post perfusion for subjects at week 2 - Subject 3 was withdrawn | Posted | Mean | Standard Error | mL/kg/min | week 2 | legs | legs |
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| Primary | Blood Perfusion Assessment - mL/kg/Min | Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied. Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min) | change in pre and post perfusion for subjects at week 3 - Subject 3 was withdrawn after treatment 2 - Subjects 9 and 10 were withdrawn after treatment 2 | Posted | Mean | Standard Error | mL/kg/min | week 3 | legs | legs |
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| Primary | Blood Perfusion Assessment - mL/kg/Min | Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied. Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min) | change in pre and post perfusion for subjects at week 4 - Subject 3 was withdrawn after treatment 2 - Subjects 9 and 10 were withdrawn after treatment 2 - Subject 8 did not complete - Subject 16 perfusion check was not measured | Posted | Mean | Standard Error | mL/kg/min | week 4 | legs | legs |
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| Primary | Blood Perfusion Assessment - mL/kg/Min | Demonstrate that the Thermofield device improves blood flow to the tissue region where it has been applied. Laser Doppler scanning will be done on the skin before and after application of the hyperthermia device to quantitatively measure changes in blood perfusion after treatment. Blood perfusion via laser Doppler will also be used to asses increases or decreases in blood perfusion that would indicate harm, such as decreased perfusion - Blood flow is usually given in units mL/(100 g * min) | Perfusion without treatment at week 8 - Subject 3 was withdrawn after treatment 2 - Subjects 9 and 10 were withdrawn after treatment 2 - Subject 8 did not complete | Posted | Mean | Standard Error | mL/kg/min | week 8 | legs | legs |
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| Primary | Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment | A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used. | Subject 3 was withdrawn | Posted | Mean | Standard Error | score on a scale | week 1 |
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| Primary | Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment | A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used. | Subject 3 was withdrawn | Posted | Mean | Standard Error | score on a scale | week 2 |
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| Primary | Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment | A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used. | Subject 3 was withdrawn after treatment 2 - Subjects 9 and 10 were withdrawn after treatment 2 | Posted | Mean | Standard Error | score on a scale | week 3 |
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| Primary | Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment | A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used. | Subject 3 was withdrawn after treatment 2 - Subjects 9 and 10 were withdrawn after treatment 2 - Subject 8 did not complete | Posted | Mean | Standard Error | score on a scale | week 4 |
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| Primary | Change in Comfort Level Scores of Participants Receiving Hyperthermia Treatment | A pain score/ 'How are you feeling?' survey will be used at each session before and after hyperthermia treatment. The scale of 0 meaning non pain/ feel fine to 10 being the maximum pain/ not feeling well will be used. | Subject 3 was withdrawn after treatment 2 - Subjects 9 and 10 were withdrawn after treatment 2 - Subject 8 did not complete | Posted | Mean | Standard Error | score on a scale | week 8 |
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| Primary | Safety: Number of Blister Formations | Cumulative number of blisters formed across all participants during weekly sessions from week 1 to 8 is reported in the data table. | Posted | Number | blisters observed | From week 1 through week 8 |
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| Primary | Safety: Significant Changes in Redness | Number of participants with significant changes in redness that required intervention. | Posted | Count of Participants | Participants | from week 1 through week 8 |
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| Secondary | Number of Participants Who Attended the Session | The number of participants who attend hyperthermia sessions will be documented. | Posted | Count of Participants | Participants | week 1 |
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| Secondary | Number of Participants Who Attended the Session | The number of participants who attend hyperthermia sessions will be documented. | Posted | Count of Participants | Participants | week 2 |
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| Secondary | Number of Participants Who Attended the Session | The number of participants who attend hyperthermia sessions will be documented. | Subject 3 was withdrawn after treatment 2 - Subjects 9 and 10 were withdrawn after treatment 2 | Posted | Count of Participants | Participants | week 3 |
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| Secondary | Number of Participants Who Attended the Session | The number of participants who attend hyperthermia sessions will be documented. | Subject 8 did not complete this visit | Posted | Count of Participants | Participants | week 4 |
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| 0 |
| 20 |
| 0 |
| 20 |
| 3 |
| 20 |
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| D014947 | Wounds and Injuries |
| D008919 | Investigative Techniques |