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Secondary Versus Tertiary Wound Closure in High Risk Gynecologic Abdominal Surgical Incisions
NA trial testing Tertiary Wound Closure in Surgical Incision in 8 participants. Terminated before completion.
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 8 |
| Start date | 27 February 2019 |
| Primary completion | 26 November 2020 |
| Estimated completion | 26 November 2020 |
| Sites | 1 location across United States |
Wake Forest University Health Sciences
Adults 18 to 65, female only, with Surgical Incision. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Tertiary Wound Closure | 4 | |
| Historical Wound Closure | 17 |
The number of Surgical Site Infections (SSI) within 30 days using a tertiary closure technique compared to historical controls receiving a secondary would closure.
| Group | Value | 95% CI |
|---|---|---|
| Tertiary Wound Closure | 0 | |
| Historical Wound Closure | 3 |
The length of stay as defined by the time from surgery to discharge as compared to historical controls receiving a secondary would closure.
| Group | Value | 95% CI |
|---|---|---|
| Tertiary Wound Closure | 3.5 | 3.0 – 9.5 |
| Historical Wound Closure | 5 | 3.5 – 6.5 |
The proportion of patients that return to hospital within 30 days of surgery.
| Group | Value | 95% CI |
|---|---|---|
| Tertiary Wound Closure | 0 | |
| Historical Wound Closure | 5 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Tertiary Wound Closure at 2 Weeks Post-surgery | 37.22 | ± 16.9 |
| Tertiary Wound Closure at 4 Weeks Post-surgery | 40.36 | ± 22.2 |
| Group | Value | 95% CI |
|---|---|---|
| Tertiary Wound Closure at 2 Weeks Post-surgery | 31.05 | ± 3.7 |
| Tertiary Wound Closure at 4 Weeks Post-surgery | 32.08 | ± 3.7 |
| Group | Value | 95% CI |
|---|---|---|
| Tertiary Wound Closure at 2 Weeks Post-surgery | 44.34 | ± 8.8 |
| Tertiary Wound Closure at 4 Weeks Post-surgery | 48.47 | ± 9.4 |
| Group | Value | 95% CI |
|---|---|---|
| Tertiary Wound Closure at 2 Weeks Post-surgery | 40.47 | ± 14.8 |
| Tertiary Wound Closure at 4 Weeks Post-surgery | 44.33 | ± 13.4 |
| Group | Value | 95% CI |
|---|---|---|
| Tertiary Wound Closure at 2 Weeks Post-surgery | 42.99 | ± 14.96 |
| Tertiary Wound Closure at 4 Weeks Post-surgery | 47.67 | ± 13.3 |
| Group | Value | 95% CI |
|---|---|---|
| Tertiary Wound Closure at 2 Weeks Post-surgery | 39.5 | ± 20.5 |
| Tertiary Wound Closure at 4 Weeks Post-surgery | 49.9 | ± 12.5 |
| Group | Value | 95% CI |
|---|---|---|
| Tertiary Wound Closure at 2 Weeks Post-surgery | 39.54 | ± 18.3 |
| Tertiary Wound Closure at 4 Weeks Post-surgery | 44.81 | ± 18.3 |
| Group | Value | 95% CI |
|---|---|---|
| Tertiary Wound Closure at 2 Weeks Post-surgery | 51.3 | ± 14.4 |
| Tertiary Wound Closure at 4 Weeks Post-surgery | 55.56 | ± 12.4 |
Time frame: The intended time period to follow patients for adverse events was one year; no additional adverse events were recorded after 8 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Tertiary Wound Closure |
|---|---|---|
| Sinus tachycardia | Cardiac disorders | — |
| Upper respiratory infection | Infections and infestations | — |
| Fall | Injury, poisoning and procedural complications | — |
| Urine output decreased | Investigations | — |
| Aspiration | Respiratory, thoracic and mediastinal disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Hypotension | Vascular disorders | — |
| Reaction | System | Tertiary Wound Closure |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Leukocytosis | Blood and lymphatic system disorders | — |
| Sinus tachycardia | Cardiac disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Hypotension | Vascular disorders | — |
| Abdominal distension | Gastrointestinal disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Pain | General disorders | — |
| Thrush | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| Activated partial thromboplastin time prolonged | Investigations | — |
| Alkaline phosphatase increased | Investigations | — |
| Blood bicarbonate decreased | Investigations | — |
| Blood bilirubin increased | Investigations | — |
| Creatinine increased | Investigations | — |
| Neutrophil count decreased | Investigations | — |
| Platelet count decreased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Hyperphosphatemia | Metabolism and nutrition disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — |
| Buttock pain | Musculoskeletal and connective tissue disorders | — |
| Dizziness | Nervous system disorders | — |
| Somnolence | Nervous system disorders | — |
| Anxiety | Psychiatric disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
Most-reported serious reactions: Sinus tachycardia, Upper respiratory infection, Fall, Urine output decreased, Aspiration, Hypoxia, Respiratory failure, Hypotension.
Data from ClinicalTrials.gov NCT03861065 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial.
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