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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-01292 | Other Identifier | National Cancer Institute | |
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| CCCWFU04418 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center |
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Slow accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this research study is to determine if closing a surgical wound differently is better than the procedure that is currently used. The wound will be closed with what is considered "tertiary intent." This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery. The investigators also want to see how this new wound closure process affects your quality of life.
Primary Objective
To compare the percentage of patients whose wound remained closed on postoperative day #30 after tertiary closure compared to historical controls who underwent secondary would closure. We are primarily looking at time to wound closure. We will be able to abstract this information from the postoperative clinic visit notes from patients in the "historical control" cohort. We will identify 20 patients with characteristics described in the inclusion criteria of this study who underwent laparotomy with secondary would closure during the calendar year 2018.
Secondary Objectives
To compare the proportion of acute and chronic wound infection in wounds closed with a tertiary closure technique to historical controls receiving a secondary wound closure.
To compare the length of stay of patients receiving a tertiary wound closure to historical controls receiving a secondary wound closure.
To describe the number of patients receiving a tertiary wound closure that return within 30 days of surgery as compared to historical controls receiving a secondary wound closure.
To describe the quality of life in patients receiving a tertiary wound closure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tertiary Wound Closure | Experimental | In the alternative tertiary wound closure, the wound will be partially closed rather than being left open. Sutures in the skin will be placed but not closed. A vacuum assisted closure device will be placed over the wound to help healing. After 4-7 days, the vacuum device will be removed, and the participant's doctor will close the wound. |
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| Historical Wound Closure | Active Comparator | The standard approach to your wound would be to leave it partially open and let it heal over a period of 3-6 months ("secondary closure"). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tertiary Wound Closure | Procedure | The wound will be closed with what is considered tertiary wound closure. This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Wound Closures Comparing Tertiary Wound Closure Versus Historical Controls Postoperative Day 30 | The number of surgical wounds that remained closed at postoperative day #30 after tertiary wound closure as compared to historical controls receiving a secondary wound closure. | 30 days after tertiary wound closure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Surgical Site Infections (SSI) for Tertiary Technique Versus Historical Controls | The number of Surgical Site Infections (SSI) within 30 days using a tertiary closure technique compared to historical controls receiving a secondary would closure. | 30 days after tertiary wound closure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael G Kelly, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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The study enrolled patients to receive tertiary wound closure; historical controls who received secondary wound closure during 2018 were selected for comparison. Historical Controls were not considered enrolled and were only used for comparison.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tertiary Wound Closure | In the alternative tertiary wound closure, the wound will be partially closed rather than being left open. Sutures in the skin will be placed but not closed. A vacuum assisted closure device will be placed over the wound to help healing. After 4-7 days, the vacuum device will be removed, and the participant's doctor will close the wound. Tertiary Wound Closure: The wound will be closed with what is considered tertiary wound closure. This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery. |
| FG001 | Historical Wound Closure | The standard approach to your wound would be to leave it partially open and let it heal over a period of 3-6 months ("secondary closure"). Historical Wound Closure: Participants wounds are left partially open to heal. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tertiary Wound Closure | In the alternative tertiary wound closure, the wound will be partially closed rather than being left open. Sutures in the skin will be placed but not closed. A vacuum assisted closure device will be placed over the wound to help healing. After 4-7 days, the vacuum device will be removed, and the participant's doctor will close the wound. Tertiary Wound Closure: The wound will be closed with what is considered tertiary wound closure. This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Wound Closures Comparing Tertiary Wound Closure Versus Historical Controls Postoperative Day 30 | The number of surgical wounds that remained closed at postoperative day #30 after tertiary wound closure as compared to historical controls receiving a secondary wound closure. | Three women did not meet intraoperative criteria and were not treated per protocol. One woman died 11 days after surgery due to respiratory failure; the primary outcome could not be measured at 30 days. | Posted | Count of Participants | Participants | 30 days after tertiary wound closure |
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The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.
Adverse Event data were only recorded for those patients enrolled in the study and treated according to protocol. The historical controls were not enrolled in the study and no adverse events were recorded.
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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 | Tertiary Wound Closure | In the alternative tertiary wound closure, the wound will be partially closed rather than being left open. Sutures in the skin will be placed but not closed. A vacuum assisted closure device will be placed over the wound to help healing. After 4-7 days, the vacuum device will be removed, and the participant's doctor will close the wound. Tertiary Wound Closure: The wound will be closed with what is considered tertiary wound closure. This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Nurse | Wake Forest Baptist Comprehensive Cancer Center | 336-713-3539 | arcarrol@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 | Sep 22, 2019 | Jul 25, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 5, 2021 | Aug 5, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Historical Wound Closure | Procedure | Participants wounds are left partially open to heal. |
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| Length of Hospital Stay |
The length of stay as defined by the time from surgery to discharge as compared to historical controls receiving a secondary would closure. |
| Up to 3 months after surgery |
| Proportion of Patients Returning After Surgery | The proportion of patients that return to hospital within 30 days of surgery. | Up to 30 days after surgery |
| Quality of Life Questionnaire SF-36 (Version 1) | The quality of life is estimated only in patients receiving a tertiary wound closure. Groups of questions were transformed into a 0-100 scale for eight domains. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Up to 3 months after tertiary wound closure |
| BG001 | Historical Wound Closure | The standard approach to your wound would be to leave it partially open and let it heal over a period of 3-6 months ("secondary closure"). Historical Wound Closure: Participants wounds are left partially open to heal. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Historical Wound Closure | The standard approach to your wound would be to leave it partially open and let it heal over a period of 3-6 months ("secondary closure"). Historical Wound Closure: Participants wounds are left partially open to heal. |
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| Secondary | Number of Participants With Surgical Site Infections (SSI) for Tertiary Technique Versus Historical Controls | The number of Surgical Site Infections (SSI) within 30 days using a tertiary closure technique compared to historical controls receiving a secondary would closure. | Three women did not meet intraoperative criteria and were not treated per protocol. One woman died 11 days post-surgery from respiratory failure; she is excluded from this analysis because she was not alive at 30 days post surgery. | Posted | Count of Participants | Participants | 30 days after tertiary wound closure |
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| Secondary | Length of Hospital Stay | The length of stay as defined by the time from surgery to discharge as compared to historical controls receiving a secondary would closure. | Three women did not meet intraoperative criteria and were not treated per protocol. One woman died 11 days after surgery, and is excluded from this analysis because her LOS was censored by her death. | Posted | Median | Inter-Quartile Range | days | Up to 3 months after surgery |
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| Secondary | Proportion of Patients Returning After Surgery | The proportion of patients that return to hospital within 30 days of surgery. | Three women did not meet intraoperative criteria and were not treated per protocol. One woman died 11 days post-surgery from respiratory failure and was excluded from this analysis because she was not alive 30 days post-surgery. | Posted | Count of Participants | Participants | Up to 30 days after surgery |
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| Secondary | Quality of Life Questionnaire SF-36 (Version 1) | The quality of life is estimated only in patients receiving a tertiary wound closure. Groups of questions were transformed into a 0-100 scale for eight domains. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Three women did not meet intraoperative criteria and were not treated per protocol. One woman died 11 days post surgery and did not complete the SF-36. Historical controls did not complete the SF-36 and were not participants for this study and will not be included as an arm of this study. | Posted | Mean | Standard Deviation | score on a scale | Up to 3 months after tertiary wound closure |
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| 2 |
| 5 |
| 2 |
| 5 |
| 5 |
| 5 |
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
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| Urine output decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Thrush | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Activated partial thromboplastin time prolonged | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Blood bicarbonate decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyperphosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Buttock pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Body Pain Domain |
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| General Health Domain |
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| Vitality Domain |
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| Social Functioning Domain |
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| Role-Emotional Domain |
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| Mental Health Domain |
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