Prospective, single-arm, observational study of a novel biofilm-removing desiccant agent, Debrichem for Japanese patients with chronic wounds, refractory ulcer, postoperative wound breakdown and open wounds

Prospective, single-arm, observational study of a novel biofilm-removing desiccant agent, Debrichem for Japanese patients with chronic wounds, refractory ulcer, postoperative wound breakdown and open wounds - Prospective, single-arm, observational study of a novel biofilm-removing desiccant agent, Debrichem for Japanese patients with chronic wounds, refractory ulcer, postoperative wound breakdown and open wounds

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000057090

Enrollment

Registered

2025-02-25

Start date

2023-11-25

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The subject who was diagnosed as chronic wounds, refractory ulcer, postoperative wound breakdown or open wounds

Interventions

Debrichem with standard of care such as surgical debridement, STSG or NPWT if needed for will be performed for chronic wounds, refractory ulcer, postoperative wound breakdown and open wounds to evalua

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)The patient who consented to this treatment (2)The subject who was diagnosed as chronic wounds, refractory ulcer, postoperative wound breakdown and open wounds (3)Patients diagnosed by a physician as having delayed healing of the wound site

Exclusion criteria

Exclusion criteria: (1)The patient who did not consent to this treatment (2)The patient whose biofilm could not be detected by the CC Steps biofilm detection device before using Debrichem (3)Ischemic ulcers prior to an effective revascularization (4)Neoplastic Ulcers (5)Underlying abscesses or fasciitis which require lancing (6)Underlying osteomyelitis (7)Intolerance for any of the ingredients (8)Allergies to any of the ingredients (9)Patients in pregnant and patients who may be pregnant and patients in lactating (10)Underlying cartilage (11)Dry full thickness non-viable tissue (eschar), unless removed pre-debridement (12)The patient judged by the investigator to be inappropriate as subjects of this study

Design outcomes

Primary

Measure	Time frame
Removal of biofilm and granulation tissue development at treatment site of wounds	—

Secondary

Measure	Time frame
Safety (Pain after treatment with Debrichem, Delayed Healing, Infection, devices malfunctioning etc.)	—

Countries

Japan

Contacts

Public ContactHajime Matsumura

Kumagayageka hospital Plastic surgery

hmatsu-tki@umin.ac.jp048-521-4115

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026