臨床研究等提出・公開システム

Date of registration	Dec. 05, 2019
Last modified on	Mar. 29, 2021
Trial ID	jRCTs032190153

Scientific Title	Safety of a new post-operative wound care dressing following the carbon dioxide laser treatment.
Public Title	Safety of a new post-operative wound care dressing.

Completion date	Nov. 17, 2020
Result actual enrolment	5
Baseline Characteristics	Men and women between the ages of 48 and 75 diagnosed with seborrheic keratosis.
Participant flow	Six patients agreed with this study. One case withdrew consent before CO2 laser treatment. Five patients underwent this intervention.
Adverse events	none
Outcome measures	No problems such as delayed epithelialization, secondary infections, and scar formation were noticed.
Brief summary	There was no safety problem by covering the wound surface of the CO2 laser treatment site with the wound dressing (FF).
Date of posting of results summaries	Mar. 26, 2021

Plan to share IPD	No
Plan description	none
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs032190153

Contact for Scientific Queries	Name	Hasegawa Toshio
	Affiliation	Juntendo University Shizuoka Hospital
	Address	1129 Nagaoka, Izunokuni, Shizuoka
	Telephone	+81-55-948-3111
	E-mail	t-hase@juntendo.ac.jp
Contact for Public Queries	Name	Hasegawa Toshio
	Affiliation	Juntendo University Shizuoka Hospital
	Address	1129 Nagaoka, Izunokuni, Shizuoka
	Telephone	+81-55-948-3111
	E-mail	t-hase@juntendo.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Dec. 05, 2019
Actual date of first enrollment		Feb. 07, 2020
Target sample size		5
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Outpatients who will receive the CO2 laser cauterization treatment of facial benign small tumors
	Exclusion Criteria	Patients with chronic inflammatory skin diseases (atopic dermatitis, psoriasis, pruritus, etc.)
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Seborrheic keratosis, Arochordon, Epidermal nevus, Vulgar wart, Senile pigmented spots
Intervention(s)		Apply a new wound dressing for a couple of weeks after the CO2 laser cauterization treatment.
Health Condition(s) Keyword		Facial benign small tumors
Intervention(s) Keyword		wound dressing
Primary Outcome(s)		1. Delayed epithelialization, 2. Secondary infections, 3. Scar formation

Source of Monetary Support / Secondary Sponsor	Kao Corporation
Secondary Sponsor	Not applicable

Name of Certified Review Board	Juntendo Hospital Certified Review Board
Address	3-1-3,Hongo,Bunkyo-ku,Tokyo 113-8431, Tokyo, Tokyo
Telephone	+81-3-5802-1584
E-Mail	crbjun@juntendo.ac.jp
Approval Status	Approval
Date of approval	Nov. 14, 2019

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	Mar. 29, 2021	(this page)	Changes
4	Nov. 11, 2020	Detail	Changes
3	Aug. 18, 2020	Detail	Changes
2	Feb. 13, 2020	Detail	Changes
1	Dec. 05, 2019	Detail

List of change history