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Retrospective study to assess the efficiency of a

novel wound healing patch – Zioheal

 

Introduction: 

Wound healing is a vital process for restoring skin integrity. While various wound dressings are available, there remains a need for products that effectively promote the healing of deep wounds. Zioheal, a novel wound healing patch, is designed to manage both acute and chronic wounds by keeping the area dry and disinfected, thereby accelerating healing. This retrospective study evaluates the efficacy of Zioheal in wound management.

Methodology: 

Patients of all ages and risk profiles who used Zioheal were included. Participating institutions completed a questionnaire capturing de-identified patient data, including comorbidities (e.g. diabetes and hypertension), wound characteristics (location, size, depth), healing time, patch usage, and any side effects. Data were analyzed statistically.

Results: 

Data from 40 patients were included. The mean age was 46.87 ± 18.1 years; 87.5% were male, and 62.5% were diabetic. Lower limb wounds were the most common (52%), and 58.3% involved deep wounds. Healing time ranged from 4 to 10 days (mean 5.88 ± 2.99 days). Patients used 2–12 sachets and changed dressings approximately every 1.73 days (41.5 h). No adverse effects were reported.

Conclusion: 

Zioheal was effective in promoting healing in both acute and chronic wounds, including deep wounds, without reported side effects. Its dual-action approach appears to reduce healing time and may lower treatment costs, making it a promising option in wound care.

INTRODUCTION

Wound healing is a complex process essential for restoring the skin’s barrier function. However, this process can be disrupted by various diseases, leading to chronic wounds that pose a significant medical burden.[1] Ongoing research aims to develop more effective wound therapies to reduce inpatient costs, provide long-term relief, and promote effective scar healing.[2] An ideal wound dressing should maintain a moist environment, allow gaseous exchange, act as a barrier to microorganisms, and remove excess exudates.[3] Oxygen is crucial for cell growth and metabolism.[4] Chronic wounds severely impact patients, particularly those with conditions such as obesity and diabetes, which interfere with normal healing. These wounds include diabetic foot ulcers, pressure ulcers, vascular ulcers, and infected wounds.[5] In diabetic patients, inadequate oxygen supply to wounds is a major challenge, often leading to hospitalization or amputation.[4] The healing process is influenced by various factors, including the environment, nutrition, and medication, making wound monitoring essential for timely treatment.[6] Tailored wound dressings are currently used based on the stage of healing, inflammatory state, moisture levels, and exudate production.[6] Transdermal drug delivery via patch formulations offers advantages such as ease of fabrication, efficient drug loading and delivery, and affordability.[5] Microneedles have gained attention in wound healing dressings due to their ability to penetrate the skin and enhance drug delivery efficiency.[7]

Recently, antimicrobial dressings have emerged as a promising approach for controlling bioburden and promoting wound healing.[8] Silver, known for its antibacterial, anti-inflammatory, and antioxidant properties, has been widely used in treating chronic wounds, particularly as silver sulfadiazine for burn-related injuries.[9] Silver-based preparations are commonly applied in burns, ulcers, surgical wounds, and chronic wounds.[8]

Zioheal is a medical device designed for managing both acute and chronic surface wounds, including abrasions, bites, ulcers, and infected wounds. Treating infected wounds remains challenging due to antibiotic resistance, highlighting the urgent need for smart biomaterials.[10] Despite substantial investments in antibiotic research, bacterial resistance is increasing rapidly.[9] Skin wounds are particularly susceptible to bacterial infections, which prolong healing, impact patients’ quality of life, and increase healthcare costs and mortality risks.[10]

Iodine is also recognized for its antimicrobial and anti-inflammatory properties, which aid in reducing microbial burden and promoting healing.[8] Zioheal combines an iodophor with a hygroscopic agent, allowing the wound to dry and disinfect in a single step. The antiseptic effect of iodine is rapid and remains active throughout using the Zioheal dressing, minimizing infection risks and accelerating the healing process.

Aim

This study aims to study the efficacy and safety of Zioheal when used for acute and chronic wounds.

 

METHODOLOGY

Ethics statement

Ethics Committee Approval was taken MH/IEC/2025/May/02.

Materials and methods

This study is an observational, retrospective study done in multiple healthcare institutions that aimed to assess the effectiveness of the Zioheal wound dressing in both acute and chronic wound management. The required information was obtained through a Zioheal-related questionnaire [Appendix 1].

The study included 40 patients who underwent treatment at different healthcare facilities with no age or underlying risk factor restriction. Data were gathered from medical records containing specific details of the wounds and their treatment processes. The online patient survey which included [Appendix 1]:

  1. Diabetes, hypertension, peripheral vascular disease
  2. Wound attributes (dimensions, depth, infected/not infected, pus)
  3. Details of the treatment, including prior wound treatment, applied antibiotics, and dressing change frequency
  4. Zioheal application information, such as sachets utilized and treatment duration
  5. Healing assessments for the time taken to achieve complete closure of the wound
  6. Patients were given the chance to report any adverse impacts experienced.

Inclusion criteria

  1. Patients treated with Zioheal for wound management
  2. Patients with acute or chronic wounds from varied etiologies such as surgical wounds, diabetic ulcers, and pressure ulcers.

Exclusion criteria

  1. Patients treated with other wound care treatments
  2. Incomplete or absent patient charts
  3. Patients with severe systemic infection necessitating extended systemic antibiotics for more than routine wound management
  4. Acute bleeding wounds.

Primary outcome

Time to healing of the wound, which is the time to complete epithelialization or reduction in the size of the wound.

Secondary outcomes

  • Wound size reduction during the treatment course
  • Infection control is measured by pus presence, signs of secondary infection, and necessity for extra antibiotics
  • Number of dressing changes as opposed to the standard wound dressing
  • Patient-rated comfort and convenience of use
  • Side effects, including irritation or delayed healing.

Statistical analysis

Descriptive statistics (mean and median as appropriate) were applied in analyzing the wound healing rates, infection control, and dressing change frequency (Microsoft Excel software). Between-wound-type and patient risk factors (e.g. diabetes, hypertension), a comparison was carried out to see trends. The data gathered were displayed in graphical and tabular forms to show healing progress and treatment results.

RESULTS

The study analyzed data from 40 patients across various institutions. The mean age of the patients was 46.87 ± 18.1 years [Table 1]. The majority (87.5%) were male. 62.5% had diabetes, 16.6% were hypertensive, and 12.5% had both diabetes and hypertension. In addition, 8.3% of patients were diagnosed with peripheral vascular disease. The average fasting blood sugar level among the patients was 138.75 ± 23.48 mg/dL during treatment.



Table 1: 
Demographics and key findings in the study

Regarding wound severity, 58.3% had deep wounds [Table 2], while the remaining had superficial wounds. It was found that 29.1% had infected wounds (oozing pus), and 16.6% had wounds that were both deep and infected. The average size of the wound was 10.6 ± 7.7 cm2. Fifty-two percent of the wounds were on the lower limbs, 30% were on the anterior part of the trunk (including chest and abdomen), and 18% were on the back and genital areas.

 


Table 2: 
Characteristics of wounds

Each patient used between 2 and 12 sachets, with a median of 3 sachets. The average duration of treatment with Zioheal patch was 5.875 ± 2.99 days. The overall healing process took an average of 9.7 ± 5.44 days, demonstrating its effectiveness in wound management and recovery. The average duration for which each patch could be used before it got soiled was 1.73 days (roughly 41.5 h).

DISCUSSION

Wound healing can be complicated by several factors, including infection, hypoxia/ischemia, and malnutrition. Immunocompromised patients are particularly vulnerable to complications, as they lack the reserves to overcome setbacks such as infection or ischemia.[6] The management of chronic and acute wounds involves controlling infection, promoting tissue regeneration, and maintaining an optimal healing environment. Various wound dressings, such as silver-based, hydrogel, and iodine-containing dressings, have been developed to address these challenges.

An ideal dressing material should create the right milieu to enhance healing. Therefore, they should absorb the purulent material or serous secretions and provide a constant supply of antiseptic/antibiotics, at the same time have healing tissue enhancing chemicals that can promote healing. There are numerous dresses that claim to be ideal; however, they do not have all the features of ideal dressing materials.

Most dressings that are available have sponge-like material to absorb secretions and one of the many chemicals as an antiseptic or antibacterial agent.

Silver dressings have become increasingly popular for managing wounds, particularly chronic wounds healing by secondary intention. These dressings provide a moist wound environment and can handle excessive exudate, aid in debridement, and promote stalled healing.[5] However, their efficacy in clinical settings remains debated, with limited strong evidence from randomized trials meeting Cochrane Collaboration criteria.[5] Silver, copper, and iodine have been used in dressings to inhibit bacterial growth.[11,12,13]

Zioheal has a unique composition of zeolite granules. Zeolyte has been shown to be safe on human tissues and is hygroscopic in nature.[14] Iodine is coated on these granules to help the dispersion of iodine slowly as the wound is kept dry. Zioheal comes in a sachet so that the granules are mobile in the sachet; this design allows the granules to conform to the wound anatomy and allows for equal distribution of granules and hence the iodine. Multiple patches can be applied to larger wounds. The cloth material that is used in Zioheal happens to be non-woven fabric – and hence is more absorptive – thus enhancing the healing power of the dressing.

Recent advancements in wound care have explored multilayer hydrogel dressings, which offer moisture control, antimicrobial action, and controlled drug release.[8] These dressings integrate biocompatible polymers such as carboxylated polyvinyl alcohol, gelatin, and hyaluronic acid to create an optimal healing environment.[8] A key advantage of multilayer hydrogels is their ability to provide sustained antibiotic release while minimizing systemic exposure, thus reducing the risk of resistance development.[8] However, challenges remain, including high production costs, risk of layer delamination, and the need for further in vivo studies.

Compared to hydrogels, Zioheal offers a simpler, cost-effective alternative using zeolite crystals to absorb exudate and iodine for antimicrobial action. Zioheal mainly functions by drying and disinfecting the wound in a single step, potentially making it more suitable for exudative wounds where moisture control is essential.

In contrast, Zioheal utilizes iodine, which is a well-known antiseptic, and it helps reduce microbial burden while promoting wound drying. Unlike silver, iodine-based formulations may have lower cytotoxicity risks and reduced resistance development, making them a viable alternative in wound care. Povidone iodine is the most frequently used antiseptic in hospitals.[15]

Deep wounds, such as those seen in diabetics, peripheral vascular disease patients, and people with bedsores, pose a challenge.[16] Routine dressing starts floating after a few hours of application as the pus accumulates in the depths of the wound and lifts the dressing. When a layer of pus develops, the dressing becomes ineffective as the antibacterial agent does not reach the base of the wound. Vaccum-assisted dressing is the alternative, but the cost of these dressing is very high and, in cases of prolonged treatment, can be a financial burden on the family.[17] Zioheal with its unique qualities, works well in deep wounds; as described earlier, it absorbs pus and other serous fluids, keeps the wound dry, and releases iodine where it is required the most – at the base of the wound. Further, the cloth material has been noted to induce the production of granulation tissue [Figures 1a-c and 2a-c].[18]


Figure 1: 
(a) Deep chronic wound with slough and pus, (b) After debridement, (c) Final healed wound

Figure 2: 
(a) Sternal wound deep and infected, (b) Zioheal dressing applied to the wound, (c) Sternal wound closed with secondary sutures after infection was controlled

In the present study, we have seen that the frequency of dressing change was once a day or sometimes 2 days (average of 1.73 days or 41 h) when there was less purulent material. The average duration of treatment was also between 5.875 ± 2.99 days. Most wounds treated were fully healed in 9.7 ± 5.44 days. The efficacy was equally good in diabetic and nondiabetics. The patch costs around 2.35$ per patch making it very economical.

Limitations

The study is a retrospective one and hence has the usual disadvantage of bias. The number of patients included is also limited, precluding subgroup analysis. Hence, further studies involving larger groups of patients will be needed to establish the usefulness of each subgroup.

CONCLUSION

Zioheal is effective in enhancing the healing of both acute and chronic wounds. It is economical and safe for use in deep wounds in patients with diabetes, peripheral vascular disease, and other conditions where trophic ulcers are seen.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

REFERENCES

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