
==== Front
Int Wound J
Int Wound J
10.1111/(ISSN)1742-481X
IWJ
International Wound Journal
1742-4801
1742-481X
Blackwell Publishing Ltd Oxford, UK

10.1111/iwj.70046
IWJ70046
Review Article
Review Article
A systematic review on the use of transforming powder dressing for wound care
O'Connor et al.
O'Connor Madeline J. 1 2
Ho Kelly C. 1
Sriram Nikhil 1
Fine Keenan S. 1
Melnick Bradley A. 1 3
Bartler Angelica V. 1
Huffman Kristin N. 1
Marzouk Sammer M. 1
Galiano Robert D. https://orcid.org/0000-0001-9552-6483
1 robert.galiano@nm.org

1 Division of Plastic and Reconstructive Surgery Northwestern University Feinberg School of Medicine Chicago Illinois USA
2 Plastic and Reconstructive Surgery Division Creighton University School of Medicine Phoenix Arizona USA
3 Division of Plastic and Reconstructive Surgery West Virginia School of Osteopathic Medicine Lewisburg West Virginia USA
* Correspondence
Robert D. Galiano, Northwestern Medicine Division of Plastic and Reconstructive Surgery, 675 N St Clair St Ste 19‐250, Chicago, IL 60611, USA.
Email: robert.galiano@nm.org

15 9 2024
9 2024
21 9 10.1111/iwj.v21.9 e7004620 8 2024
02 4 2024
21 8 2024
© 2024 The Author(s). International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.
https://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

Abstract

The transforming powder dressing (Altrazeal®, Uluru Inc, Addison, TX, USA) is simple to use, painless to apply and has a wear time of up to 30 days. This study aims to review the current literature to elucidate the impact of transforming powder dressing on healing, pain management and overall patient outcomes. We conducted a systematic review following Preferred Reporting Items of Systematic Reviews and Meta‐Analyses guidelines. Data including study characteristics, patient demographics and wound outcomes were extracted. Our systematic review included 26 articles (n = 175). Of these articles, 13 (50%) were case reports, 10 (38.5%) were case series, 2 (7.7%) were randomised controlled trials and 1 (3.8%) was a cohort study. Wound types included venous ulcer (23.9%), pressure sore (19.7%), burn (15.5%), skin graft (13.4%), diabetic foot ulcer (4.2%), Mohs defect (3.5%) and other (19.6%). Complete re‐epithelialization occurred in 90.1% of the wounds. A total of 19 studies (73%) discussed pain, each of which reported reduced pain with the use of transforming powder dressing. The evaluated studies collectively suggest that transforming powder dressing offers a promising re‐epithelialization rate and analgesic effect across various wound types.

burns
leg ulcer
pain
pressure sore
wound healing
source-schema-version-number2.0
cover-dateSeptember 2024
details-of-publishers-convertorConverter:WILEY_ML3GV2_TO_JATSPMC version:6.4.8 mode:remove_FC converted:15.09.2024
O'Connor MJ , Ho KC , Sriram N , et al. A systematic review on the use of transforming powder dressing for wound care. Int Wound J. 2024;21 (9 ):e70046. doi:10.1111/iwj.70046
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pmc1 INTRODUCTION

Wound care is a critical aspect of healthcare, and advancements in therapeutic modalities continually seek to enhance the healing process. The transforming powder dressing (TPD), Altrazeal®, is a biologically inert polymer composed of nanoparticles (Figure 1). It was engineered as a dressing for surgical wounds, traumatic wounds, chronic wounds and burns. It is simple and painless to apply, as the powder is sprinkled over a moistened wound. The main component in the product is 5% poly‐2‐hydroxyethylmethacrylate (pHEMA), which is a biocompatible compound initially designed for soft hydrogel contact lenses but has been used widely in medicine, including artificial corneas, breast implants and prosthesis. 1 , 2 The unique properties of pHEMA contribute significantly to its utility in wound healing, featuring attributes such as moisture retention, high oxygen permeability, antibacterial characteristics and transparency. 2 , 3

FIGURE 1 Product image.

Application of the dressing to a wound allows it to interact with ionised compounds such as saline and blood, triggering nanoparticle aggregation that conforms precisely to the contours of the wound bed. This allows the dressing to fill dead spaces in the wound to seal off the wound margins. 1 The architecture of the compound also gives it tensile strength and significant protection to the wound. 4 Furthermore, the nanoparticle aggregate's pores play a dual role, allowing for adequate wound oxygenation whilst creating a barrier against bacterial intrusion. Importantly, these pores establish a capillary channel, promoting efficient moisture removal from the wound and creating an environment conducive to optimal wound healing. 1

To ensure optimal wound healing, the initial TPD application involves cleaning and debriding the wound, then moistening the wound bed with saline or a similar solution before sprinkling the Altrazeal powder evenly over the wound. The first dressing change is typically recommended 7–10 days after the initial application, or earlier if there are signs of wound leakage or infection. TPD can be removed by lifting gently with forceps after moistening with saline for 3–5 min. Depending on the wound type and healing progress, subsequent dressing changes should occur every 7–14 days, with more frequent changes necessary for chronic or heavily exudative wounds. 5

The prevailing standard of care for wounds is nuanced and patient‐specific, contingent on factors such as chronicity, type and severity of the wound. If a wound has devitalized or infected tissue, one must thoroughly debride the wound and manage infection prior to advancing to further management. 6 Debridement methodologies encompass active and passive irrigation or surgical intervention, utilising sharp tools to eliminate infected tissue and biofilm. 6 , 7 , 8 In addition, there have been extensive studies on topical therapies following debridement that may augment wound healing; these include growth factors, antiseptic agents and medications. 9 , 10 , 11 , 12 , 13 In cases of large soft‐tissue defects, wound packing becomes integral, serving to absorb exudate and prevent infection, either post‐debridement or between serial debridements, particularly for wounds with excessive physiologic dead space. 14 Wound closure depends on the size of the wound and infectious status. Small acute wounds can often be closed by primary closure with sutures, staples or adhesives. If a wound is infected, delayed primary closure may be necessary to allow for debridement and microbial clearance prior to closure. 15 Wounds may require skin grafts or flap coverage if they are too large for primary closure.

Effective wound dressing remains pivotal across the spectrum of acute and chronic wounds. A diverse array of dressing types, including films, foams, alginates, hydrocolloids, hydrogels and hydroactives, may be employed based on the wound's specific characteristics. However, the most important qualities when choosing a dressing are its ability to maintain optimal moisture levels and facilitate gas exchange for healing, and an assessment of the wound should be conducted prior to the selection of the optimal dressing. 14 , 16 , 17

TPD has numerous purported benefits, including enhancement of wound healing, pain reduction, cost reduction and reduced care time. Given that it is simple to apply, it also provides an additional method of wound care in patients who are not optimal surgical candidates. TPD is widely available in several countries, including the United States, Canada, many European nations, parts of Asia and Australia, and multiple studies across a wide spectrum of wound types have reported on its efficacy. To the best of our knowledge, there is no systematic review that summarises the results of these studies. This systematic review aims to provide an examination of the available literature on TPD, from randomised controlled trials (RCTs), observational studies and other relevant sources. We seek to elucidate the impact of TPD on wound healing, pain management and overall patient outcomes.

2 METHODS

This systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) guidelines. 18 The corresponding protocol was registered in PROSPERO (Registration ID: CRD42023485051).

2.1 Literature search

A systematic literature search was performed to identify relevant peer‐reviewed articles and abstracts that were written in English and published between 1 January 2003 and 1 November 2023, and indexed in PubMed, The Cochrane Library, OVID, EMBASE and Scopus. The search strategy used the following terms:‘Altrazeal’ OR ‘Altrazeal powder’ OR ‘Altrazeal transforming powder’ OR ‘Altrazeal dressing’ OR ‘Altrazeal transforming powder dressing’ OR ‘Transforming powder dressing’ OR ‘Powder dressing’ OR ‘Methacrylate powder dressing’ OR ‘Methacrylate dressing’ OR ‘Methacrylate transforming powder dressing’ OR ‘Wound powder’ OR ‘Bioactive powder’ OR ‘Bioactive wound powder’ OR ‘Nanoflex powder dressing’ OR ‘Nanoflex dressing’ OR ‘Nanoflex powder’

2.2 Eligibility criteria

Only articles and abstracts reporting on the use of TPD in the management of wounds or burn injuries in humans were included. Additionally, studies were included only if they contained primary data (RCTs, case series and case reports) and reported on at least one of the following endpoints: time to wound closure, wound size reduction, duration of therapy, clinical signs of infection, pain level, cost of treatment and care time spent during dressing changes. Meta‐analyses, review articles, preclinical animal or bench studies and veterinary studies were excluded from the review.

2.3 Literature screening/selection process

Titles of articles and abstracts that met search criteria were logged and duplicates were removed. Each remaining study was assessed for inclusion and exclusion criteria by two independent reviewers. When discordance was identified, two naive reviewers resolved the conflict. Articles and abstracts that met all inclusion criteria and no exclusion criteria were read critically by at least two independent reviewers to identify any additional references that met inclusion/exclusion criteria and to extract study information. A full‐text review was carried out on all eligible articles by two independent reviewers. A third reviewer resolved any inconsistencies.

2.4 Data collection

Data were extracted from the selected studies using a standardised form created with Google Sheets. The data points extracted included study characteristics, patient demographics (age, gender and race), wound attributes (type, location, severity and age), prior treatments, inpatient vs. outpatient treatment setting, TPD application details (duration of use, frequency of reapplication, type of hydration solution used and application procedure), treatment outcomes, complications and study limitations.

2.5 Quality assessment

The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. The risk of bias within individual studies was assessed using the Risk of Bias of Nonrandomized Studies of Interventions (ROBINS‐I) tool, and findings were incorporated into the interpretation of results.

2.6 Statistical analysis

For the statistical analysis, frequencies and percentages were calculated for categorical variables such as wound type, wound location and treatment setting. Continuous variables such as age, duration of TPD use and frequency of application were summarised using mean and median values along with measures of dispersion (standard deviation, interquartile range and range as appropriate). Given the heterogeneity of study designs and the presence of non‐comparable groups (case reports, case series and RCTs), a meta‐analysis was not conducted.

For comparative analysis, where data allowed, appropriate statistical tests, including the Mann–Whitney U test for nonparametric data, were used to compare outcomes between acute and chronic wounds, different wound locations and other relevant subgroups. Patient‐reported outcomes, such as pain reduction, were narratively synthesised given the qualitative nature of these findings.

All statistical analyses were performed using R and a p‐value of less than 0.05 was considered statistically significant. The results of this synthesis are presented narratively, in tables, and graphically where applicable, to provide a comprehensive overview of the efficacy and safety of Altrazeal in wound management.

3 RESULTS

3.1 Study characteristics

The initial database search yielded 580 articles. After removing duplicates (n = 98), we performed a title and abstract screen of 482 articles. We deemed 36 abstracts to be eligible for full‐text review. Additionally, we retrieved six studies from citation searching. All 6 articles were found to be eligible in the title and abstract screen. We performed a full‐text review on a total of 42 articles, of which 16 were deemed ineligible. Thus, 26 articles met the inclusion criteria and were therefore included in the data extraction (Figure 2). 1 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 Of these articles, 13 (50%) were case reports, 10 (38.5%) were case series, 2 (7.7%) were RCTs and 1 (3.8%) was a cohort study (Figure 3). Half of these articles (13/26) were published in 2022 or 2023 (Table 1). A total of 175 patients were included in this review. Of those patients, 33 were randomised to a standard‐of‐care (SOC) group and therefore did not undergo treatment with TPD. The median number of subjects included was 2.5 (interquartile range = 2). The mean age was 48.2 (range 5–94) years. Of the studies that reported patient gender, 87 patients (67%) were male. Few papers reported patient race. Most studies that were included were of low quality. Most studies included had a moderate risk of bias, predisposing this review to an overall moderate risk of bias (Table 2).

FIGURE 2 Search strategy.

FIGURE 3 Level of evidence pyramid.

TABLE 1 Characteristics of included studies.

Author	Year	Study design	# Subjects	Type of wound (burn, pressure injury, MOHS, etc.)	Acute versus chronic	
Abd Elhakeem et al.	2022	Case series	30	Burn: 17 (56.7%)

Pressure sore: 7 (23.3%)

Trauma: 3 (10%)

Venous ulcer: 3 (10%)

	Acute: 20 (66.7%)

Chronic: 10 (33.3%)

	
Alkhatieb et al.	2020	Case report	1	Diabetic foot ulcer	Chronic	
Anaya et al.	2022	Case series	4	Acne inversa	Chronic	
Assadian et al.	2015	RCT	19	Split‐thickness skin graft donor site	Acute	
Bickers	2022	Case series	3	Burn: 1 (33.3%)

Diabetic foot ulcer: 1 (33.3%)

Trauma: 1 (33.3%)

	Chronic	
Derakhshan et al.	2022	Case report	1	Diabetic foot ulcer	Chronic	
Fraccalvieri et al.	2014	Case report	1	Venous leg ulcer	Chronic	
Fitzgerald et al.	2009	Case report	1	Necrotizing fasciitis	Acute	
García Carretero et al.	2018	Case report	1	Venous leg ulcer	Chronic	
Lichtman et al.	2023	Case series	3	Enterocutaneous fistula: 1 (33.3%)

Dehiscence of the abdominal wall: 1 (33.3%)

Open abdominal wound/rectal stump: 1 (33.3%)

	Chronic: 1 (33.3%)

Not reported: 2 (66.7%)

	
Lin et al.	2023	Case report	1	Mohs defect	Acute	
Lin et al.	2019	Case report	1	Mohs defect	Acute	
Lin	2019	Case series	3	Venous leg ulcer	Chronic	
Mahmood et al.	2023	RCT	60	Venous leg ulcers	Chronic	
Marinovic et al.	2014	Case report	1	Hardware infection of the lower leg	Chronic	
Nie et al.	2023	Case series	3	Pilonidal cysts	Chronic	
Pek et al.	2018	Case series	3	Burn	Acute	
Saxe et al.	2022	Case series	3	Vasculitis ulcer: 1 (33.3%)

Burn: 1 (33.3%)

Complex abdominal wound: 1 (33.3%)

	Chronic: 1 (33.3%)

Acute: 2 (66.7%)

	
Smith et al.	2019	Case report	1	Mohs defect	Acute	
Smith	2020	Case report	1	Dystrophic epidermolysis bullosa	Acute	
Smith	2019	Case report	2	Mohs defect	Acute	
Soghomonyan et al.	2017	Cohort study	6	Diabetic foot ulcer	Acute	
Sotomayer et al.	2022	Case series	3	Necrotizing fasciitis	Acute	
Thompson et al.	2023	Case report	1	Radiation	Chronic	
Thompson et al.	2023	Case report	1	Spider bite	Acute	
Yu et al.	2022	Case series	21	Pressure ulcer	Chronic	
Abbreviations: CS, case series; CR, case report; RCT, randomised controlled trial.

TABLE 2 Level of evidence and risk of bias assessment.

Author	Level of evidence	Quality a	Risk of bias a	
Abd Elhakeem et al. 18	4	Low	Moderate	
Alkhatieb et al. 19	4	Low	Moderate	
Anaya et al. 20	4	Low	Moderate	
Assadian et al. 21	1	Moderate	Low	
Bickers 22	4	Very low	Serious	
Derakhshan et al. 23	4	Low	Moderate	
Fitzgerald et al. 1	4	Low	Moderate	
Fraccalvieri et al. 24	4	Low	Serious	
García Carretero et al. 25	4	Low	Moderate	
Lichtman et al. 26	4	Low	Serious	
Lin et al. 27	4	Low	Moderate	
Lin et al. 28	4	Low	Moderate	
Lin et al. 29	4	Low	Serious	
Mahmood et al. 30	1	High	Low	
Marinovic et al. 31	4	Low	Serious	
Nie et al. 32	4	Low	Serious	
Pek et al. 33	4	Low	Moderate	
Saxe et al. 34	4	Low	Serious	
Smith et al. 35	4	Very low	Serious	
Smith 36	4	Very low	Serious	
Smith 37	4	Low	Serious	
Soghomonyan et al. 38	4	Very low	Serious	
Sotomayer et al. 39	4	Low	Moderate	
Thompson et al. 40	4	Low	Moderate	
Thompson et al. 41	4	Low	Moderate	
Yu et al. 42	4	Low	Moderate	
a Study quality was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Risk of bias was assessed using the Risk of Bias of Nonrandomized Studies of Interventions (ROBINS‐I) tool.

3.2 Wounds treated

The type and location of wounds varied significantly across studies. The most common wound type for which TPD was applied was venous ulcer (n = 34, 23.9%), followed by pressure sore (n = 28, 19.7%), burn (n = 22, 15.5%), skin graft (n = 19, 13.4%), diabetic foot ulcer (n = 6, 4.2%), Mohs defect (n = 5, 3.5%), abdominal wound (n = 4, 2.8%), trauma (n = 4, 2.8%), acne inversa (n = 4, 2.8%), chronic leg ulcer (n = 4, 2.8%), necrotizing fasciitis (n = 4, 2.8%), pilonidal cyst (n = 3, 2.1%) and other (n = 5, 3.5%). The most common wound location for which TPD was applied was the legs (n = 50, 35.2%), followed by the feet (n = 28, 19.7%), sacrococcygeal region (n = 19, 13.3%), arms (n = 6, 4.2%), back (n = 6, 4.2%), buttocks (n = 6, 4.2%), hands (n = 4, 2.8%), abdomen (n = 4, 2.8%), ischial region (n = 4, 2.8%), chest (n = 3, 2.1%) and other (n = 4, 2.8%). Eight wounds (5.6%) did not have a reported wound location. Patients were treated for chronic wounds in 65.1% (n = 114) of cases and acute wounds in 34.9% (n = 61) of cases. Saline was the most common solution used to hydrate TPD, however, a betaine‐polyhexanide solution (Prontosan) was used in 2 cases (1.4%). The majority of TPD applications were performed in an outpatient setting (61.3%, n = 87), whilst few were done in an inpatient setting (2.1%, n = 3). Approximately ⅓ of the articles did not make it evident in which setting patients were treated with TPD (36.6%, n = 52). The mean duration of TPD use was 63.9 days (range 5–168). There was a statistically significant difference in mean duration of TPD use when wounds were categorised as acute or chronic (p = 0.0483); mean duration of TPD use for chronic wounds was on average significantly higher than that of acute wounds. The median frequency of TPD application across all studies was every 7 days (range 3–28). A total of 19 studies (73%) discussed patient‐reported pain measures following the use of TPD. Several studies reported substantial decreases in patient‐reported pain following TPD application. Other studies reported patients' qualitative perception, noting that TPD commonly led to reduced pain and enhanced patient comfort due to decreased dressing changes. One RCT of 19 patients showed a statistically significant difference (p < 0.001) in patient‐reported pain when comparing the experimental (TPD applied) and control group (no TPD applied). 22 One case series of 21 patients reported a decrease in pain scores from an average of 8–9/10 to 1–2/10 within one application of TPD. 43 No studies mentioned any complications for patients treated with TPD. Of the wounds treated with TPD, the vast majority (n = 128, 90.1%) showed complete epithelialization without a need for further treatment. In an RCT of 60 patients, 87% of patients who received TPD showed complete epithelialization at 24 weeks compared to only 40% of the control group. 31 Only three studies explicitly mentioned the percentage reduction in wound size. The average wound size reduction percentage across the three studies was 96.3%. 28 , 29 , 30 The time points at which wound healing was measured varied widely across studies (1–24 weeks). In one case series of 3 patients, one patient showed complete epithelialization at 1 week, another patient showed complete epithelialization at 4 weeks and the third patient showed complete epithelialization at 8 weeks. 33

4 DISCUSSION

This review describes the current evidence on the various uses and efficacy of the transforming powder dressing Altrazeal®.

TPD is currently indicated for use as a primary dressing for surgical wounds, traumatic wounds and chronic wounds. 44 Numerous studies have reported on the efficacy of TPD for these various indications, but to the best of our knowledge, this is the first review that has summarised data on the outcomes of TPD across numerous wound settings.

In our present study, we reviewed 26 articles with a total of 175 patients (142 patients underwent treatment with TPD). Numerous wound indications were evaluated in these studies, including ulcers (venous, pressure and diabetic foot), Mohs wounds, skin graft sites, burns (scald, chemical, flame and friction), traumatic wounds, acne inversa, epidermolysis bullosa, necrotizing fasciitis, colorectal abdominal wounds, pilonidal cysts, radiation and spider bites. In most cases, SOC treatments were initially attempted and failed prior to the use of TPD. Despite these drastically different indications, the vast majority of patients experienced significant improvement with the use of TPD. This indicates great promise as most of these wounds were incredibly challenging to treat, as indicated by the failed SOC measures tried before TPD that were described in most of these studies. Furthermore, there were no reported complications with the use of TPD. This evidence supports the use of TPD as a wound care method when SOC methods fail. As we describe below, this evidence may in fact support TPD as a first‐choice wound care method given its ease of use and analgesic properties.

As mentioned above, there were a variety of wounds that were treated with TPD versus SOC. Some SOC dressings include silver‐containing carboxymethylcellulose dressing (CMC‐Ag), NPWT and compressive dressings. In one study, Assadian et al compared TPD to CMC‐Ag for split‐thickness skin graft donor sites in burn patients. 22 Whilst the sample size was small, yielding insignificant differences in time to wound healing, the study found TPD was significantly more comfortable for patients and had significantly lower pain with the use of TPD compared to CMC‐Ag. Other included studies report the improvements of hard‐to‐heal wounds with TPD compared to NPWT. 1 , 26 Fitzgerald et al. reported a case of necrotizing fasciitis in which the patient underwent debridement, and NPWT without improvement of the tissue defect, thus changing treatment to TPD. The authors found a reduction of the dead space within the wound after the use of TPD, allowing for a healthy wound to emerge for definitive wound closure. The authors also reported decreased pain in association with TPD when compared to NPWT. García Carretero et al reported a case of a non‐healing venous leg ulcer after debridement, failure with multilayer dressing leading to hyperbaric oxygen therapy, and NPWT, which made the wound worse. However, after 20 weeks of application of TPD, the wound achieved near complete re‐epithelialization. Both of these case reports demonstrate the clear patient benefit of using TPD versus NPWT, with improvement of the wound bed as well as reduction of patient‐reported pain. Lastly, Mahomood et al found that in comparison to the standard compressive dressing, TPD resulted in significantly higher rates of complete healing in chronic venous ulcers, less time to heal, less required dressing changes and less pain. Future studies should expand on the differences of each respective treatment in larger randomised controlled studies.

In addition to its demonstrated efficacy, there are multiple reasons why TPD is appealing to not only patients but to providers as well. Firstly, TPD is incredibly simple to use. Application instructions include cleaning/hydrating the wound with normal saline followed by pouring the powder on top to cover the entire wound bed. 44 TPD has a wear time of up to 30 days, at which time more TPD can be added to the site without needing to remove the primary application of TPD. TPD itself dries and flakes off as the wound heals, decreasing the need for constant dressing changes. This is an important contrast to the frequency of dressing changes required for most SOC dressing types, which can range from every 4–6 h for wet‐to‐dry dressings to every 48–72 h for negative pressure wound therapy. 45 In our current study, dressing changes with TPD occurred approximately every 7 days. It is unclear why the frequency of dressing changes was not extended closer to the 30‐day mark in most of the included studies, and this should be the subject of further investigation. That being said, the possibility of extending wear time up to 30 days with TPD is significant for multiple reasons. Firstly, dressing changes with SOC techniques can be extremely painful for patients. TPD offers a painless application process and requires far fewer dressing changes. Secondly, frequent dressing changes are very costly, as skilled nurse visits are often required to carry out the dressing changes. Given that TPD is incredibly simple to use, skilled nursing visits are often not required for its application and patients may take an active role in caring for their wounds. This simple application process and reduced frequency of dressing changes may also reduce the caretaker burden. A prospective RCT should be performed to allow for a cost–benefit analysis directly comparing the cost of care with TPD versus SOC for the above indications to better understand the cost‐efficiency.

Interestingly, several of the included studies indicated that TPD had a pain reduction effect on patients. This pain reduction is independent of the additional reduced pain experienced during dressing changes, and thus indicates that the product itself may have analgesic properties. The study by Yu et al. reported a significant decrease in patients' pain levels, dropping from an initial 8 or 9/10 to a 1 or 2/10 following the first dressing change. 43 Similarly, in the case report by Thompson, a patient with a brown recluse spider bite was reporting pain levels of 4 to 5/10 at baseline and increasing to 10/10 with dressing changes. This escalation in experienced pain required the use of narcotic medications for patient pain management. Following the first application of TPD, the patient reported pain scores of 1/10, which allowed for the cessation of narcotics for pain control. 42 The study by Fitzgerald et al. also reported a reduction in pain with the use of TPD. 1 Although the precise mechanism of the pain reduction associated with TPD use remains unclear, one hypothesis suggests a reduction in inflammation via vapour transpiration, which may also produce a cooling effect on the wound, contributing to pain alleviation. 1 Further research on the exact mechanism of analgesia associated with this product should be performed.

4.1 Limitations

Our study has numerous limitations. Although we reviewed 26 studies, only 2 of those studies were prospective RCTs and most of the studies were case series or case reports. Furthermore, there is a high variability in the reporting of wound types, locations and outcomes and many studies lacked detailed descriptions of these measures. The time points of primary endpoints also varied widely amongst the studies. There is also a lack of standardisation amongst the studies regarding the length and number of applications of TPD to wounds. These studies demonstrated a paucity of variation in sex, age and race amongst the patients in their cohorts. The majority of our studies only included male patients (67%), and younger cohorts with a median age of 48.2 years. Within our reviewed articles, there was a paucity of details of the patient's race and ethnicity both of which have an extremely important impact on wound and pain outcomes. The limited sample size, limited patient‐reported pain outcomes, lack of standardisation and lack of variability of sex, age and race demonstrate some avenues in which future studies should investigate.

In addition to the variability amongst the studies, publication bias must be considered when discussing the effectiveness of TPD powders. Given that positive results are more likely to be reported, this paper may overestimate the effectiveness of Altrazeal. Publication bias may be further compounded by the number of case studies and series in this review, which inherently highlight noteworthy outcomes. To reduce future risk of publication bias in reviews of TPD, more RCTs must be conducted and the data should also include unpublished studies, if available. Furthermore, it must be noted that multiple studies were written with the support of ULURU Inc., which may introduce significant bias.

4.2 Future directions

With the limitations mentioned above, there is a need for further research to be conducted to alleviate the paucity of information in several areas. First, there is a need for more prospective studies to be conducted to understand more about how TPD applications can impact various wound locations and types, and how they can affect patient pain outcomes. Patient‐reported pain outcomes with TPD usage are lacking in the literature, and incorporating this into future studies will allow a better understanding of the other uses TPD may offer. Future prospective studies should also strive for a diverse cohort, including patients of various ages, sex and races to allow for a better understanding of how TPD can benefit all patients in terms of wound and pain outcomes. It is important that these future studies consider populations that are underrepresented in medicine whether due to barriers to access, economic burden, race or ethnicity. These factors can allow for a better understanding of whether there are strengths or weaknesses in TPD usage in diverse wound etiologies and chronicity. Overall, further research must be conducted for there to be a better comprehensive understanding of TPD and wound outcomes.

5 CONCLUSION

This systematic review has undertaken a thorough examination of the existing literature regarding the application of TPD in wound management, with a specific emphasis on its efficacy in wound healing and its impact on pain. The evaluated studies collectively suggest that TPD demonstrates promising results across various wound types, encompassing surgical wounds, traumatic wounds, chronic wounds and burns. Whilst the interpretation of these findings warrants caution due to the inherent diversity in study designs and possible bias, the promising outcomes associated with the use of TPD signal a compelling narrative for its utility in clinical practice.

CONFLICT OF INTEREST STATEMENT

Dr. Galiano receives research funding from Altrazeal Life Sciences. All other authors have no competing interests to report.

ACKNOWLEDGEMENTS

We thank the team at Altrazeal Life Sciences for providing us with articles for which we did not have access.

DATA AVAILABILITY STATEMENT

The data that support the findings of this study are available from the corresponding author upon reasonable request.
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