Closed-Incision Negative Pressure Therapy Compared to Conventional Dressing Following Autologous Abdominal Tissue Breast Reconstruction: The MACVAC Pilot Randomized Control Trial
Bibliographic record
Abstract
Introduction: There is equipoise regarding the use of closed-incision negative pressure therapy (ciNPT) versus conventional dressings for abdominal incisions in deep inferior epigastric perforator (DIEP) flap breast reconstruction. The primary objective was to determine the feasibility of conducting a randomized controlled trial (RCT) comparing ciNPT versus conventional dressings for abdominal incisions in DIEP flap breast reconstruction. Methods: A parallel, between-group randomized controlled pilot trial was conducted at two academic breast reconstruction centers. Participants were included if they were adult female patients (≥18 years old) receiving immediate or delayed DIEP flap breast reconstruction. Participants were excluded if they were pregnant, had an allergy to adhesive dressings, or had a body mass index ≥40 kg/m 2 . Primary feasibility outcomes were attaining a 90% eligibility rate, 85% recruitment rate, and 85% retention rate. Secondary outcomes were abdominal site complications and patient-reported health-related quality of life measurements. Block randomization was performed in a 1:1 ratio intraoperatively following abdominal incision closure. Outcome assessment was performed by a blinded assessor. Results: There were 12 patients randomized to each group. The eligibility rate was 90.6%, recruitment rate was 86.2%, pre-randomization retention rate was 96.0%, and post-randomization retention rate was 95.8%. Wound dehiscence rates were 16.7% in the intervention and 41.7% in the control group. Conclusion: The full RCT was deemed feasible based on a priori feasibility outcomes. The anticipated sample size will be 54 patients per group to achieve adequate statistical power. The full multicenter trial is currently in the recruitment process. Trial Registration: NCT04985552.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.005 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".