Negative pressure wound therapy versus usual care for Surgical Wounds Healing by Secondary Intention (SWHSI trial): study protocol for a randomised controlled pilot trial

Arundel, Catherine; Buckley, Hannah; Clarke, Emma; Cullum, Nicky; Dixon, Stephen; Dumville, Jo C; Fairhurst, Caroline; Firth, Anna; Henderson, Eileen; Lamb, Karen; McGinnis, Elizabeth; Oswald, Angela; Gonçalves, Pedro; Soares, Marta; Stubbs, Nikki; Torgerson, David; Chetter, Ian

doi:10.1186/s13063-016-1661-1

Cited by 14 publications

(11 citation statements)

References 9 publications

(6 reference statements)

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“…This is a fast moving field. Even with this specific design of single-use NPWT device, new studies are being published regularly, and there are many studies ongoing as noted by published protocols [ 49–52 ] or listing on public registries, such as . Evidence is broader for SSI than for dehiscence or LOS, and it has not yet been possible to individually analyze for superficial, deep, or organ space SSI.…”

Section: Discussionmentioning

confidence: 99%

Meta-Analysis of Comparative Trials Evaluating a Prophylactic Single-Use Negative Pressure Wound Therapy System for the Prevention of Surgical Site Complications

Strugala¹,

Martin²

2017

Surgical Infections

121

109

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Background: We report the first meta-analysis on the impact of prophylactic use of a specific design of negative pressure wound therapy (NPWT) device on surgical site complications.Methods: Articles were identified in which the specific single-use NPWT device (PICO⋄, Smith & Nephew) was compared with standard care for surgical site infection (SSI), dehiscence, or length of stay (LOS). Risk ratio (RR) ±95% confidence interval (CI) (SSI; dehiscence) or mean difference in LOS ±95% CI was calculated using RevMan v5.3.Results: There were 1863 patients (2202 incisions) represented by 16 articles. Among 10 randomized studies, there was a significant reduction in SSI rate of 51% from 9.7% to 4.8% with NPWT intervention (RR 0.49 [95% CI 0.34–0.69] p < 0.0001). There were six observational studies assessing reduction in SSI rate of 67% from 22.5% to 7.4% with NPWT (RR 0. 32 [95% CI 0.18–0.55] p < 0.0001). Combining all 16 studies, there was a significant reduction in SSI of 58% from 12.5% to 5.2% with NPWT (RR 0.43 [95% CI 0.32–0.57] p < 0.0001). Similar effects were seen irrespective of the kind of surgery (orthopedic, abdominal, colorectal, or cesarean section), although the numbers needed to treat (NNT) were lower in operations with higher frequencies of complications. There was a significant reduction in dehiscence from 17.4% to 12.8% with NPWT (RR 0.71 [95% CI 0.54–0.92] p < 0.01). The mean reduction in hospital LOS by NPWT was also significant (−0.47 days [95% CI −0.71 to −0.23] p < 0.0001).Conclusions: The significant reduction in SSI, wound dehiscence, and LOS on the basis of pooled data from 16 studies shows a benefit of the PICO single-use NPWT system compared with standard care in closed surgical incisions.

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Section: Discussionmentioning

confidence: 99%

Meta-Analysis of Comparative Trials Evaluating a Prophylactic Single-Use Negative Pressure Wound Therapy System for the Prevention of Surgical Site Complications

Strugala¹,

Martin²

2017

Surgical Infections

121

109

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“…Our outcome is the status of the wound within the first 12 weeks of treatment initiation, coded dichotomously into healed versus not healed, as commonly used in clinical trials of wound treatment. 22,23 While patients can remain in treatment for longer than 12 weeks, wound healing in that period was no longer considered for the analysis. Following Ennis et al, we applied a modified intent-to-treat approach in that wounds in patients lost to follow-up during the 12 weeks were considered not healed after excluding wounds that were followed for <7 days.…”

Section: Definition Of Outcomementioning

confidence: 99%

Development of a Model to Predict Healing of Chronic Wounds Within 12 Weeks

Cho

Mattke

Gordon³

et al. 2020

Advances in Wound Care

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Pré cis: Using both clinically informed and machine learning approaches, we developed a prediction model for chronic wound healing that can form the basis for quality measurement. Objective: Chronic wounds represent a highly prevalent but little recognized condition with substantial implications for patients and payers. While better wound care products and treatment modalities are known to improve healing rates, they are inconsistently used in real-world practice. Predicting healing rates of chronic wounds and comparing to actual rates could be used to detect and reward better quality of care. We developed a prediction model for chronic wound healing. Approach: We analyzed electronic medical records (EMRs) for 620,356 chronic wounds of various etiologies in 261,398 patients from 532 wound care clinics in the United States. Patient-level and wound-level parameters influencing wound healing were identified from prior research and clinician input. Logistic regression and classification tree models to predict the probability of wound healing within 12 weeks were developed using a random sample of 70% of the wounds and validated in the remaining data. Results: A total of 365,659 (58.9%) wounds were healed by week 12. The logistic and classification tree models predicted healing with an area under the curve of 0.712 and 0.717, respectively. Wound-level characteristics, such as location, area, depth, and etiology, were more powerful predictors than patient demographics and comorbidities. Innovation: The probability of wound healing can be predicted with reasonable accuracy in real-world data from EMRs. Conclusion: The resulting severity adjustment model can become the basis for applications like quality measure development, research into clinical practice and performance-based payment.

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“…In addition, there are currently two clinical trials in progress to help determine the efficacy of NPWT in midline abdominal incisions. 13,14 Our experience suggests that primary skin closure or NPWT with Hydrofera Blue bacteriostatic foam wicks can facilitate early wound closure with no increase in SSOs. Both of these methods decrease wound VAC days and discharge without a wound VAC.…”

Section: Discussionmentioning

confidence: 92%

Comparison of a standardized negative pressure wound therapy protocol after midline celiotomy to primary skin closure and traditional open wound vacuum-assisted closure management

Regner

Forestiere

Maldonado

et al. 2018

Baylor University Medical Center Proceedings

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A negative pressure wound therapy (NPWT) protocol using Hydrofera Blue Ò bacteriostatic foam wicks and silver-impregnated foam overlay to close midline skin incisions after emergency celiotomy was compared to primary skin closure only and traditional open wound vacuum-assisted closure management as part of a quality improvement initiative. This single-institution retrospective cohort study assessed all consecutive emergency celiotomies from July 2013 to June 2014 excluding clean wounds. Included variables were demographics, wound classification, NPWT days, and surgical site occurrences (SSOs). Primary outcome was days of NPWT. Secondary outcomes included SSOs (surgical site infections, fascial dehiscence, return to operating room). Analysis used exact chisquare between categorical variables, Kruskal-Wallis for analysis of variance for ordinal and categorical variables, and Wilcoxon rank sum for total days of NPWT. One hundred fifty-eight patients underwent emergency celiotomy with primary skin closure (n D 51), open NPWT (n D 63), or the NPWT protocol (n D 44). There was no difference in American Society of Anesthesiologists Physical Status score, body mass index, wound classification, or SSO between the three groups. Total NPWT days were reduced in protocol versus open NPWT (median 3 vs 20.5 days, range 3-51 vs 3-405 days, P D 0.001). Primary skin closure and NPWT protocol had fewer patients discharged with NPWT than open NWPT (0% and 14% vs 63.5%, P < 0.0001, odds ratio D 10.7, 95% confidence interval 3.7-35.1). Primary skin closure and NPWT protocol decrease NPWT usage days and maintain low SSOs in emergency midline celiotomy incisions.

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Negative pressure wound therapy versus usual care for Surgical Wounds Healing by Secondary Intention (SWHSI trial): study protocol for a randomised controlled pilot trial

Cited by 14 publications

References 9 publications

Meta-Analysis of Comparative Trials Evaluating a Prophylactic Single-Use Negative Pressure Wound Therapy System for the Prevention of Surgical Site Complications

Meta-Analysis of Comparative Trials Evaluating a Prophylactic Single-Use Negative Pressure Wound Therapy System for the Prevention of Surgical Site Complications

Development of a Model to Predict Healing of Chronic Wounds Within 12 Weeks

Comparison of a standardized negative pressure wound therapy protocol after midline celiotomy to primary skin closure and traditional open wound vacuum-assisted closure management

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