Trial reportSurgical infections2014
Comparison of digital planimetry and ruler technique to measure ABSSSI lesion sizes in the ESTABLISH-1 study.
Trial report in Surgical infections, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06919809 (Efficacy and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix), which is not on this map. Cited by 3 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Efficacy and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix (mADM) for Enhancing Wound Healing Following Mohs Micrographic Surgery (MMS)
Who cites it
3 citing papers in PubMed.
- Comparison of Digital Planimetry and Ruler Methods for the Measurement of Extraction Socket Wounds.Medicina (Kaunas, Lithuania) · 2023Article
- Measuring Surface Area of Skin Lesions with 2D and 3D Algorithms.International journal of biomedical imaging · 2019Article
- Treatment outcome measures for randomized controlled trials of antibiotic treatment for acute bacterial skin and skin structure infections in the emergency department setting.International journal of emergency medicine · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn August 2010, the U.S. Food and Drug Administration issued draft guidelines for developing antibiotics for treating acute bacterial skin and skin structure infections (ABSSSI), with the outcome measure of such treatment relying primarily on the cessation of spread or on the decrease in size of skin lesions at 48-72 h after the initiation of such treatment. In 2012, the Foundation for the National Institutes of Health proposed an interim outcome measure defined as a reduction in lesion size by ≥20% at a 48-72 h examination. These recent changes make it necessary to identify reliable methods for measuring the lesions in acute infections of the skin.
methodsIn the first study of the Efficacy and Safety of 6-day Oral Tedizolid in Acute Bacterial Skin and Skin Structure Infections vs. 10-day Oral Linezolid Therapy (ESTABLISH-1), the sizes of ABSSSI lesions were evaluated with the two methodologies of: (1) Digital planimetry (DP) of photographed lesions, and (2) a ruler technique (RT) with measurement of the longest head-to-toe length and greatest perpendicular width of lesions, to compare the respective response rates of lesions to the two antimicrobial regimens in the study.
resultsThe RT method and DP showed similar percentages of subjects in which treatment stopped the spread of ABSSSI lesions (93.2% vs. 94.2%, respectively) but showed less agreement for a reduction in lesion size, of ≥20% (87.7% vs. 62.0%, respectively) across all categories of lesions (cellulitis/erysipelas, major cutaneous abscess, and acute wound infection) at 48-72 h after the initiation of treatment.
conclusionThe results of the ESTABLISH-1 study show that both the RT method and DP are consistent and reliable techniques for measuring the sizes of ABSSSI lesions. Ultimately, changes in lesion size, rather than the absolute value of lesion size, will be used to assess the outcomes of treatment for ABSSSI in clinical research.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.