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 machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.008 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 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 source (direct Gemma or distilled Codex), 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".