OTR4120: topical application to split-skin graft donor sites. A clinical evaluation on the healing.

OTR4120: topical application to split-skin graft donor sites. A clinical evaluation on the healing. - OTR4120 to skin-graft donor sites

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33585

Enrollment

Registered

2009-04-17

Start date

2009-07-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

burn wounds donor skin

Interventions

Wetted compresses, soaked in OTR4120 or placebo, will be placed on parts of the wound during 5 minutes.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Informed consent 2. Aged over 18 yrs 3. Patients in need of an autologous skin graft 4. Adequate nutritional state 5. Adequate immuno-competence 6. Women in reproductive age take contraceptive medication

Exclusion criteria

Exclusion criteria: 1- Minor patients 2- Pregnant or breastfeeding women 3- Patients unable to sign the informed consent 4- Uninsured patients

Design outcomes

Primary

Measure	Time frame
-Clinical improvement of the donor site wound, measured as reduction in wound size in time.	—

Secondary

Measure	Time frame
-Complete healing of the wound, measured as the time needed for complete healing. -Improvement of the quality of the (former) wound area to be measured as the amount of vascularisation, skin pigmentation and elasticity. -Pain reduction. -Itch reduction.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)