Trial · NCT07907705
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
NCT07907705, Not yet recruiting, Dávid Ágoston Kovács
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds. Trials, record NCT07907705. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07907705
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
- NCT number
- NCT07907705
- Status
- Not yet recruiting
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Dávid Ágoston Kovács
- Conditions
- Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection, Surgical Wound Dehiscence, Mesh-Associated Wound Complications
- Interventions
- Negative Pressure Wound Therapy (NPWT)
- First posted
- 2026-10-30
- Last updated
- 2026-10-30
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in aortic pulse wave velocity (PWVao) from baseline to cessation of the index NPWT episode | T0: within 60 minutes before first NPWT activation; T1: day 5 (days 3-7); T2: within 24 hours before or after cessation of the index NPWT episode (variable treatment duration). | Change in aortic pulse wave velocity (PWVao), measured in m/s using the Arteriograph TL2. Each standard-condition session is the mean of the first three valid PWVao acquisitions. The primary estimate is the mean arterial pressure (MAP)-adjusted T2-minus-T0 difference, with a 95% confidence interval, from a random-intercept mixed model incorporating T0, T1 and T2, categorical visit, and separate within-person and between-person MAP components. Observed unadjusted T0-T2 paired changes will also be reported. A negative change indicates lower measured arterial stiffness. T0 precedes foam placement. T2 is assessed before planned definitive closure and reflects cessation of the index NPWT episode for any reason, not necessarily wound healing. |
| Secondary | Association between PWVao change and percentage wound-cavity volume reduction | Vascular T0: within 60 minutes before first NPWT activation; vascular T2: within 24 hours before or after index-episode cessation. Volume is measured at the corresponding encounters, before definitive closure. Treatment duration varies. | Prespecified Model A coefficient relating T2-minus-T0 PWVao change (m/s) to percentage wound-cavity volume reduction (PVR), adjusted for T2-minus-T0 mean arterial pressure (MAP) change. PVR = 100 x (V0 - V2)/V0, using saline-fill volumes in mL. Report m/s per 10-percentage-point greater PVR, with 95% CI and a supplementary nominal P value when estimable. Require standard awake, interpretable T0-T2 vascular pairs, matched MAP, and valid same-encounter vascular-volume pairs at both visits with V0 \> 0. Retain negative PVR and valid pairs flagged for debridement or other wound-altering procedures. Missing or unmeasurable volumes are not assigned zero or 100% reduction. Fit only with sufficient predictor variation, a full-rank design, positive residual degrees of freedom and finite standard errors and confidence intervals, as prespecified; otherwise report individual data without a regression estimate. |
| Secondary | Change in native aortic augmentation index (AIxao) | T0: within 60 minutes before first NPWT activation; T1: day 5 (days 3-7); T2: within 24 hours before or after cessation of the index NPWT episode, before planned definitive closure. Treatment duration varies. | Native aortic augmentation index (AIxao) measured using the Arteriograph TL2 at T0, T1 and T2. Each session value is the mean of the first three valid AIxao acquisitions, with technical validity assessed independently of PWVao. Native values are expressed as percentages and changes as percentage points. The main contrast is the T2-minus-T0 difference, adjusted for concurrent heart rate using the prespecified longitudinal mixed model, with a 95% confidence interval. Heart rate is obtained from the same acquisitions used for AIxao. No conversion to AIx at a standardized heart rate of 75 beats/min is performed. |
| Secondary | Percentage reduction in saline-fill wound-cavity volume | T0, T1 (target day 5, days 3-7) and T2 wound assessments in the same encounters as the corresponding core vascular recordings; main volume comparison T0 to T2 at index-episode cessation, with variable treatment duration. | Arithmetic mean of patient-specific percentage volume reductions (PVR), each 100 x (V0 - V2)/V0, with a two-sided t-based 95% CI when at least two valid pairs permit calculation. This is not the ratio of group mean volumes. Report n, SD, median and IQR as supporting summaries. Use valid same-encounter saline-fill volumes and V0 \> 0. Negative PVR is retained. Debridement, mesh procedures and deliberate reopening are flagged. No reproducibly fillable residual cavity or loss of the operational filling endpoint during healing is a distinct reason for missing volume, not an assumed zero; a closed wound also has no unmeasured zero. T1 is supportive. The PWVao-PVR association is specified as a separate secondary outcome. |
| Secondary | Change in C-reactive protein concentration | Routine blood samples within 24 hours before or after T0, T1 (target day 5, days 3-7) and T2 core vascular assessments; main comparison T0 to T2 at index-episode cessation, with variable treatment duration. | Arithmetic mean signed T2-minus-T0 CRP change in mg/L on the raw scale, with a two-sided t-based 95% CI when at least two valid pairs permit calculation. Report n, SD, median and IQR as supporting summaries; negative change indicates a decrease. Select the closest routine collection by absolute time within +/-24 hours of each vascular assessment; ties favor the earlier sample. Record collection times and signed intervals. Change and Model B require two distinct selected blood collection events; reused samples make change missing. Do not substitute another sample to force a pair or draw extra research blood. T1 is supportive. Secondary Model B relates PWVao change to signed CRP change/10 and MAP change, with the raw-scale slope in m/s per 10 mg/L higher signed CRP change, 95% CI and a supplementary nominal P value when estimable. It is an analysis, not an additional outcome. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07907705
GET https://conductscience.org/api/trials/v1/NCT07907705/registered