New mesh-free dressing promotes skin wound healing in EB: Trial data
Patients reported dressing changes were painless 95% of the time
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A new mesh-free dressing developed using lipidocolloid technology (TLC) promotes the healing of various types of skin wounds, including those associated with fragile skin caused by epidermolysis bullosa (EB).
That’s according to data from the HEAL clinical trial (NCT03640871), which evaluated the new dressing in 78 adults, ages 23-95, with acute or chronic skin wounds and EB-related lesions.
Healthcare professionals rated the dressing as “very easy” or “easy” to apply in 96% of wounds, including hand and finger wounds, while patients reported that dressing changes were painless 95% of the time.
“The innovative mesh-free TLC dressing was shown to promote wound healing, to be well tolerated and well accepted by patients and [healthcare professionals],” researchers wrote.
The study, “An innovative, highly conformable, mesh-free healing matrix dressing: results of a clinical trial,” was published in the Journal of Wound Care.
TLC wound dressing creates moist environment conducive to healing
EB is a group of rare skin disorders marked by fragile skin that easily blisters and tears. When blisters burst, they can be painful and become infected. After they heal, the remaining scar tissue can cause deformities.
Effective wound management involves selecting dressings based on the wound characteristics, the surrounding skin condition, the location of the wound on the body, and patient sensitivities. Pain is a common issue during care, particularly during the removal of dressings and wound cleansing.
TLC is a wound dressing that promotes healing by creating a moist environment conducive to healing. It works via a gel that contacts the wound, supporting cell growth while preventing the dressing from sticking to the wound, thus ensuring pain-free removal. For more than two decades, TLC’s efficacy and tolerance, when combined with textile mesh, have been well-documented, according to the scientists.
A new generation of TLC dressings, composed entirely of a lipidocolloid matrix without textile mesh, has recently been developed. Unlike earlier TLC versions, it doesn’t adhere to gloves, can be cut for customized application, and suits difficult-to-dress areas such as hands, feet, and joints.
Four weeks of TLC dressing reduced median wound area by 98.2% overall
In the HEAL study, researchers in France evaluated the performance and local tolerance of this new TLC dressing in managing various types of wounds, including those caused by EB.
In total, 78 adults, ages23 to 95, were treated with the dressing for an average of 24 days.
Of those with EB, four had dystrophic EB, and one had junctional EB. All EB patients had skin lesions, while four had lesions in the ear, nose, and throat. In addition, three had digestive tract lesions, three had eye lesions, and three had abnormalities in the extremities.
Acute wounds included dermabrasion (cosmetic surgery) or skin tears, traumatic or postoperative wounds located on fingers, skin graft donor sites, second-degree burns, and other postoperative wounds. Acute wounds were most frequently on the leg, hand/fingers, and thigh. Chronic wounds included leg ulcers and pressure injuries.
Before entering the study, 66 patients treated their wounds with various dressings — most commonly foam, greasy gauze, contact layer, and alginate. Although most dressings were easy to remove, more than half stuck to the wound bed. Removal often caused bleeding and moderate-to-severe pain, with some patients requiring painkillers before wound care.
According to trial data, four weeks of the new TLC dressing resulted in a 98.2% reduction in the median wound area overall, ranging from 61.5% for chronic wounds to 100% for EB lesions and acute wounds.
Complete wound closure was achieved in almost half (49%) of patients overall, including 60% with EB lesions, 59% of those with acute wounds, and 16% with chronic wounds. The median time to heal was 16.5 days for all healed wounds, ranging from 14.5 days for acute wounds to 18 days for EB wounds and 27 days for chronic wounds.
The efficacy and local tolerance of this new TLC dressing appear to be similar to that of TLC dressings in the management of cutaneous wounds, including in cases of fragile skin such as in patients with EB. These results support the use of this non-adherent, atraumatic, and flexible healing matrix dressing in the local treatment of cutaneous wounds.
From the first application, healthcare professionals rated the dressing as “very easy” or “easy” to apply in 96% of wounds and as having “very good” or “good” conformability to 94% of wound beds. Comparable results were seen for finger and hand wounds. Clinicians also reported that the dressing “did not stick to the medical gloves” in 99% of cases.
By the first week, dressing removal was considered “very easy” or “easy” in 95% of cases, consistently protecting and preserving newly formed tissue in 100% of cases. By the final visit, participating healthcare professionals indicated that they would recommend this new TLC dressing to their colleagues, with a median score of 9 out of 10.
At the first follow-up visit, patients reported that dressing changes were painless in 95% of cases, with similar results reported at weeks 2, 3, and 4. This represented a significant improvement over their previous experience with dressings, the team noted.
Overall, seven non-serious adverse events deemed possibly or probably related to the new TLC dressing were reported during the study. This included two cases of contact dermatitis (itchy rash due to direct contact with a substance or an allergic reaction to it), two new lesions, one case of pruriginous lesions (small, itchy, dome-shaped bumps), one case with heavy wound bleeding, and one case of severely dry skin (xerosis).
“The efficacy and local tolerance of this new TLC dressing appear to be similar to that of TLC dressings in the management of cutaneous wounds, including in cases of fragile skin such as in patients with EB,” the researchers concluded. “These results support the use of this non-adherent, atraumatic, and flexible healing matrix dressing in the local treatment of cutaneous wounds.”
