Prospective cohort study: evaluation of the treatment of deep thermal Hand burns in Adults with NexoBrid® in the Dutch population

Prospective cohort study: evaluation of the treatment of deep thermal Hand burns in Adults with NexoBrid® in the Dutch population - HAND study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46955

Enrollment

Registered

2018-04-13

Start date

2017-03-14

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

burn scars

Interventions

hand burns

Nexobrid

thermal

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * *18 years * Patients with clinically judged acute deep partial thickness or mixed deep partial and full thickness burns of one or both hands that are treated with NexoBrid® * Competent or temporary incompetent (because of sedation and/or intubation)

Exclusion criteria

Exclusion criteria: * Insufficient knowledge of the Dutch language

Design outcomes

Primary

Measure	Time frame
Hand function as measured by the modified Kapandji Index (MKI), goniometry, sensation, strength, Jebsen-Taylor test	—

Secondary

Measure	Time frame
Scar quality as measured by the POSAS and quality of life as measured by validated questionnaires. Other secondary study parameters include: the incidence of patients requiring surgical excision and percentage of surgical excision, the incidence of patients requiring autografting and percentage of autografting, the time to reach wound healing (defined as re-epithelialization >95%), the need for escharotomy due to burn-induced compartment syndrome, the incidence of bacterial colonization and wound infection, the length of hospital stay, pain, itching, edema, return to work and the description of the revalidation treatment. Other study parameters include: age, gender, Body Mass Index (BMI), cause of burn, TBSA%, BSA% of the hands, co-morbidities, medication.	—

Measure

Time frame

Scar quality as measured by the POSAS and quality of life as measured by validated questionnaires. Other secondary study parameters include: the incidence of patients requiring surgical excision and percentage of surgical excision, the incidence of patients requiring autografting and percentage of autografting, the time to reach wound healing (defined as re-epithelialization >95%), the need for escharotomy due to burn-induced compartment syndrome, the incidence of bacterial colonization and wound infection, the length of hospital stay, pain, itching, edema, return to work and the description of the revalidation treatment. Other study parameters include: age, gender, Body Mass Index (BMI), cause of burn, TBSA%, BSA% of the hands, co-morbidities, medication.

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)