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Efficacy and safety of a new post-operative wound care dressing following the carbon dioxide laser treatment.

Efficacy and safety of a new post-operative wound care dressing.

30

Subject: 30 Age (mean): 61 (39 - 82) Male: 15 Female: 15

The study protocol specified a target number of 30 patients and a single-center, evaluator-blind, nonrandomized, within-subject, controlled trial of actual medication. Consent was obtained from 32 of the recruited potential participants; of the 32, 30 who met the selection criteria and did not meet the exclusion criteria were enrolled as subjects. Of the 30 subjects enrolled, 3 subjects withdrew from the study due to study drug noncompliance, and 27 subjects completed the study. The efficacy and safety analyses were performed on all 30 enrolled subjects, respectively, according to the study protocol (excerpts below). Year 1 Consent obtained in 14 cases, Number of study subjects under treatment: 12 cases Year 2: Consent obtained in 18 patients, Number of study subjects under treatment: 18 cases

No disease was reported during the subjects' participation in the study. The number of adverse events was 0 for steroid-applied sites and 0 for microfiber-applied sites. Secondary infection and scar formation, which were defined as safety endpoints in the research protocol, also occurred in 0 cases at the steroid-applied site and 0 cases at the microfiber-applied site.

The primary endpoint was the crust score evaluated photographically by a third-party physician as described in the study protocol and statistical analysis plan. The value immediately after carbon dioxide laser treatment was used as baseline, and the difference between each data and baseline was taken on the second postoperative day for the microfiber-applied or steroid-applied site, and further, the between-group difference (BGD) from the differences for the microfiber sheet-applied site and the steroid-applied site was calculated. The final BGD in difference from baseline was compared to zero value by Wilcoxon signed rank test. The results showed that the mean BGD at baseline was -0.022 and the mean BGD at postoperative day 2 was -0.083 (P=0.3541), which was not significantly different. Secondary endpoints were as specified in the study protocol and statistical analysis plan as follows: third-party physician photographic evaluation score (erythema score, epithelialization score, and pigmentation score), physician evaluation score (crusting score, erythema score, epithelialization score, pigmentation score, and swelling score), instrumental measurement quantitative values (melanin content, hemoglobin content L, a, b*, concavity, and scar area), and the same statistical analysis was performed as for the primary endpoint. Among the secondary endpoints, a significant improvement was observed in epithelialization score (after 1 week), erythema score (after 1 week), a* value (after 1 week and 2 weeks), and scar area (after 2 weeks, 1 month, and 2 months) in the microfiber-applied area compared to the steroid-applied area. No significant differences were observed in other parameters.

The microfiber sheets were found to be as effective as steroids in the primary and secondary endpoints. In addition, the photographically-evaluated crust score by a third-party physician showed a significant improvement effect in the areas where the microfiber sheets were applied. In the product evaluation by the subjects, the microfiber sheet was rated higher than steroids in terms of the good feeling and intention to use.

Dec. 31, 2024

No

undecided

https://jrct.mhlw.go.jp/latest-detail/jRCTs032210690

Hasegawa Toshio

Juntendo University Shizuoka Hospital

1129 Nagaoka, Izunokuni, Shizuoka

t-hase@juntendo.ac.jp

Hasegawa Toshio

Juntendo University Shizuoka Hospital

1129 Nagaoka, Izunokuni, Shizuoka

+81-55-948-3111

t-hase@juntendo.ac.jp

Complete

Mar. 22, 2022

Interventional

non-randomized controlled trial

open(masking not used)

active control

single assignment

treatment purpose

Outpatients who will receive the CO2 laser cauterization treatment of facial or neck benign small tumors

Patients with chronic inflammatory skin diseases (atopic dermatitis, psoriasis, pruritus, etc.)

Both

seborrheic keratosis, soft fibroma, epidermal nevus

Apply a new wound dressing and steroid ointment for a couple of weeks after the CO2 laser cauterization treatment

Facial or neck benign small tumors

wound dressing, steroid ointment

Crust score by photo

Score by photo, Visual assessment, 3D image value, Questionnaire

+81-3-5802-1584

Feb. 22, 2022

none