Abdominal Negative Pressure Wound Therapy Devices for Management of the Open Abdomen

Crumley, Carolyn

doi:10.1097/won.0000000000000862

Cited by 3 publications

(5 citation statements)

References 20 publications

(169 reference statements)

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“…From 336 articles, 21 that downloaded MAUDE data files were set aside for further analysis 11–31 . Upon manual review, 135 articles with unclear queries 32–164 and 120 with incomplete queries 165–284 were excluded. Ultimately, 60 executable queries were found 5,10,285–342 .…”

Section: Methodsmentioning

confidence: 99%

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

Li,

Feng,

Gong

et al. 2024

J Patient Saf

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Objective This article aims to assess the reproducibility of Manufacturer and User Facility Device Experience (MAUDE) data-driven studies by analyzing the data queries used in their research processes. Methods Studies using MAUDE data were sourced from PubMed by searching for “MAUDE” or “Manufacturer and User Facility Device Experience” in titles or abstracts. We manually chose articles with executable queries. The reproducibility of each query was assessed by replicating it in the MAUDE Application Programming Interface. The reproducibility of a query is determined by a reproducibility coefficient that ranges from 0.95 to 1.05. This coefficient is calculated by comparing the number of medical device reports (MDRs) returned by the reproduced queries to the number of reported MDRs in the original studies. We also computed the reproducibility ratio, which is the fraction of reproducible queries in subgroups divided by the query complexity, the device category, and the presence of a data processing flow. Results As of August 8, 2022, we identified 523 articles from which 336 contained queries, and 60 of these were executable. Among these, 14 queries were reproducible. Queries using a single field like product code, product class, or brand name showed higher reproducibility (50%, 33.3%, 31.3%) compared with other fields (8.3%, P = 0.037). Single-category device queries exhibited a higher reproducibility ratio than multicategory ones, but without statistical significance (27.1% versus 8.3%, P = 0.321). Studies including a data processing flow had a higher reproducibility ratio than those without, although this difference was not statistically significant (42.9% versus 17.4%, P = 0.107). Conclusions Our findings indicate that the reproducibility of queries in MAUDE data-driven studies is limited. Enhancing this requires the development of more effective MAUDE data query strategies and improved application programming interfaces.

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Section: Methodsmentioning

confidence: 99%

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

Li,

Feng,

Gong

et al. 2024

J Patient Saf

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“…11 Overt ACS may require a decompression laparotomy, with the resultant open abdomen often managed with abdominal negative pressure wound therapy. 6,23 WOC nurses working in acute care can serve as champions within their hospitals to implement IAP monitoring on at-risk patients. Intravesical devices as an extension of indwelling urinary catheters fall well within the continence scope of practice, and patients with IAP/ACS are likely to also need wound care in relation to an open abdominal incision and percutaneous tubes, as well as possible ostomy care.…”

Section: Indications For Iap Measurement and Acs Managementmentioning

confidence: 99%

“…Excessive fluids may be removed with diuretics or continuous renal replacement therapy,7,8 with paracentesis as indicated for tense ascites 11. Overt ACS may require a decompression laparotomy, with the resultant open abdomen often managed with abdominal negative pressure wound therapy 6,23…”

Section: Clinical Application: Measuring Iapmentioning

confidence: 99%

“…Intravesical pressure measurements as a proxy for IAP do not appear to be affected by active abdominal negative pressure wound therapy. 23 However, manufacturer guidelines for AbThera (3M+KCI, St Paul, Minnesota) note that if IAH or ACS is suspected, to note IAP, turn the negative therapy off, allow foam to fully expand, and obtain a new reading to confirm. 23 Contraindications to using intravesical devices include a history of cystectomy, traumatic bladder injury, and pelvic packing.…”

Section: Clinical Application: Measuring Iapmentioning

confidence: 99%

“…23 However, manufacturer guidelines for AbThera (3M+KCI, St Paul, Minnesota) note that if IAH or ACS is suspected, to note IAP, turn the negative therapy off, allow foam to fully expand, and obtain a new reading to confirm. 23 Contraindications to using intravesical devices include a history of cystectomy, traumatic bladder injury, and pelvic packing. 11…”

Section: Clinical Application: Measuring Iapmentioning

confidence: 99%

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Intra-Abdominal Pressure Measurement Devices

Crumley¹

2022

Journal of Wound, Ostomy &Amp; Continence Nursing

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PURPOSE:The purpose of this Technologic Analysis is to review devices designed to measure intra-abdominal pressure (IAP); these devices are used to detect intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS). APPROACH: Published literature focusing on devices designed to measure IAP was reviewed, comparing the options available and outlining recommendations for appropriate use. Safety information regarding IAP measurement devices was derived from the Manufacturer and User Facility Device Experience (MAUDE) database. CONCLUSIONS: Intra-abdominal hypertension is prevalent among critically ill patients of all ages and is linked to adverse consequences, such as abdominal compartment syndrome. The condition is often unrecognized due to the lack of overt clinical symptoms, supporting the need for devices to accurately measure IAP. Commercially available devices measure IAP indirectly, typically via the bladder or stomach. Additional research is needed to demonstrate the benefi ts of routine screening, further defi ne risk factors for IAH/ACS development, and evaluate the impact of measures to reduce IAP in an effort to improve patient outcomes.

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Abdominal vacuum therapy is a component of DAMAGE CONTROL SURGERY tactics for combat trauma to the abdomen

Aslanyan,

Bily,

Sobko

et al. 2024

Medicni Perspektivi

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The goal of the study was to improve the outcomes of surgical care and treatment for patients with combat-related abdominal injuries at different levels of medical support during combat operations by using abdominal vacuum therapy as a component of Damage Control Surgery tactics. At the II level of combat medical support within the Damage Control Surgery tactics, abdominal vacuum therapy was applied to 75 wounded male combatants with a combat abdominal injury, aged 37.4±8.3 years (main group). The comparison group consisted of 87 wounded patients aged 37.5±10.2 years, operated on using Damage Control Surgery tactics with drainage of the abdominal cavity and suturing of the skin only. 40.0% of the wounded in the main group and 46.0% of the comparison group were admitted with signs of traumatic shock of various degrees. According to the AdTS scale, 78.7% of the wounded in the main group were admitted in a serious condition, 21.3% – in an extremely serious condition; in the comparison group, 74.7% were in severe condition, 25.3% were in extremely severe condition. In 57.3% of the wounded of the main group, abdominal vacuum therapy was carried out in the irrigation-flow mode. 24.0% used standard bandages for abdominal vacuum therapy, 76.0% used partially improvised ones. The level of negative pressure was set in the range of 40-125 mm Hg in constant mode. Intra-abdominal pressure was measured by a standard method (through the bladder) at admission and after surgery. The assessment of the state of the abdominal cavity in the I and III phases of Damage Control Surgery was carried out according to the Abdominal Cavity Index scale – an integral assessment expressed in points based on factors that can be assessed visually during surgery. The volume of surgical interventions in the 1st phase of the Damage Control Surgery tactic depended on the nature of the damage to the abdominal organs and the condition of the wounded. After the completion of Phase I of Damage Control Surgery tactics, all wounded were evacuated by road medical transport and medical helicopters to the next level of medical support, with abdominal vacuum therapy during evacuation in the main group and Damage Control Resuscitation measures. Under the effect of abdominal vacuum therapy, the reduction of intra-abdominal pressure in the main group was pronounced (Δ=9.2; p<0.01) than in the comparison group (Δ=6.1; p<0.01). Abdominal vacuum therapy during the II phase of the Damage Control Surgery tactic made it possible to clean the abdominal cavity better (p<0.0001) than in the comparison group and provided better preparation for the implementation of the III phase of this tactic. As a result, reliable protection from external factors, active prevention of intra-abdominal pressure and rehabilitation of the abdominal cavity during the application of abdominal vacuum therapy during the II phase of Damage Control Surgery tactics in the main group of wounded after obstructive resections of the small intestine in the I phase made it possible to completely abandon terminal stomas in the III phase (in the comparison group – 5) in favor of the formation of small bowel intestinal anastomoses, and during obstructive colon resections, the number of terminal colostomas in the main group was reduced to 50.0% (in the comparison group -90.9%, р=0.004), also in favor of the formation anastomoses, which significantly improved the functional results of providing assistance to the wounded with a combat abdominal injury. The use of abdominal vacuum therapy during phases I-II of the Damage Control Surgery (DCS) tactics allows for the optimization of the scope of surgical interventions in phase III of Damage Control Surgery and significantly improves the functional outcomes of surgical care and treatment for patients with combat abdominal injuries at various levels of medical support during combat operations.

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Abdominal Negative Pressure Wound Therapy Devices for Management of the Open Abdomen

Cited by 3 publications

References 20 publications

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

Intra-Abdominal Pressure Measurement Devices

Abdominal vacuum therapy is a component of DAMAGE CONTROL SURGERY tactics for combat trauma to the abdomen

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