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Randomized Controlled Trial
. 2024 Nov 22;19(1):38.
doi: 10.1186/s13017-024-00560-9.

Prophylactic PICO◊ dressing shortens wound dressing requirements post emergency laparotomy (EL-PICO◊ trial)

Eleanor Felsy Philip  1 , Retnagowri Rajandram  1 , Mariana Zuber  1 , Tak Loon Khong  1 , April Camilla Roslani  2
Affiliations
Randomized Controlled Trial

Prophylactic PICO◊ dressing shortens wound dressing requirements post emergency laparotomy (EL-PICO◊ trial)

Eleanor Felsy Philip et al. World J Emerg Surg. .

Abstract

Background: Surgical site infection (SSI) is a very common complication of emergency laparotomy and causes significant morbidity. The PICO◊ device delivers negative pressure wound therapy (NPWT) to closed incisions, with some studies suggesting a role for prevention of SSI in heterogenous surgical populations. We aimed to compare SSI rates between patients receiving PICO◊ versus conventional dressing post-emergency laparotomy. Secondary objectives were to observe seroma and dehiscence rates, length of stay, days on dressing and patients' wound experience.

Methods: This double blinded randomized controlled trial was conducted in University Malaya Medical Centre between October 2019 and March 2022. Patients undergoing emergency laparotomy requiring incisions less than 35 cm were included. Statistical analysis was performed using χ2 test for categorical variables, independent T-test or Mann-Whitney U were used for parametric or non-parametric data respectively besides logistic regression. P values of < 0.05 were considered to be significant.

Results: Ninety-six patients were analyzed (47 interventions, 49 controls). The duration on dressing was more consistent in the intervention arm (PICO◊) versus control arm [9.78 ± 10.20 vs 17.78 ± 16.46 days, P < 0.001]. There was a trend towards lower SSI [14.3 vs 4.3%, P = 0.09], dehiscence [27.1 vs 10.6%, P = 0.07] and seroma [40.8 vs 23.4%, P = 0.08] rates in the intervention arm but this did not reach statistical significance. Length of stay [9 (IQR: 6-14) vs 11 (IQR: 6-22.5) days, P = 0.18] was fairly similar between the two arms, but more patients were very satisfied with PICO◊ compared to the conventional dressing [80% vs 57.1%, P = 0.03].

Conclusion: The use of NPWT in emergency laparotomy improves patients wound care experience, and was associated with trends towards fewer wound related complications. Cost effectiveness needs to be explored in order to further validate its use in the emergency setting, especially for patients with additional risk for SSI. Trial registration National Medical Research Registry (NMRR): NMRR-20-1975-55222.

Keywords: Emergency laparotomy; Negative pressure wound therapy; PICO◊ dressing; Surgical site infection.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Ethical approval was obtained from Institutional ethical committee prior to the commencement of the study with the number MREC ID No: 202057-8603. The study was registered with the National Medical Research Register, ID No. NMRR-20-1975-55222. Informed consent forms were signed by all patients as per ethical approval guidelines. Insurance coverage was also obtained for this study, 2020-HB-L0002099-LNC. This work consent has been obtained and authors approve the final version of the manuscript. Consent for publication: This work consent has been obtained and authors approve the final version of the manuscript. Competing interests: The authors declare no competing interests.

Figures

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Consort diagram
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References

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