NCT02373566

Brief Summary

In this study the efficacy of an acellular dermal template (Novomaix), combined with split thickness skin grafts, for use in patients with full thickness skin defects, is tested. Results will be compared intra-patient with those obtained after conventional treatment with split thickness skin grafts. The investigators expect this treatment to provide better outcome regarding scar quality.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

February 23, 2015

Last Update Submit

February 13, 2020

Conditions

Full Thickness Skin Defects

Keywords

burnsdermal substitutescar qualityreconstructionwound healingwound closure

Outcome Measures

Primary Outcomes (1)

  • Scar quality as assessed for scar elasticity (experimental vs control area) as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS)

    Scar elasticity as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS)

    3 months post-operative

Secondary Outcomes (5)

  • Graft take (Subjective assessment by experienced observer)

    5-7 days

  • Epithelialisation (Subjective assessment by experienced observer)

    5-7 days and 2-3 weeks post-operative

  • Scar quality (Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire)

    12 months

  • Scar quality (As determined with subjective scar assessment scale (POSAS)

    3 and 12 months

  • Scar quality (As measured for scar colour and pigmentation using DSM II ColorMeter)

    3 and 12 months

Study Arms (2)

Dermal substitute with STSG

EXPERIMENTAL

Novomaix dermal substitute in combination with STSG

Device: Novomaix dermal substitute in combination with STSG

STSG alone

NO INTERVENTION

STSG alone

Interventions

Novomaix dermal substitute in combination with STSGDEVICE

Novomaix dermal substitute in combination with STSG

Also known as: Novomaix
Dermal substitute with STSG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years (for Zurich: ≤ 18 years)
  • Full thickness skin defects configured in such a way that two comparable and measurable areas can be grafted, both of minimally 3x3 cm
  • ≤ 50% TBSA full thickness skin defects at time of intervention
  • Informed consent by the patient and/or legal representatives.

You may not qualify if:

  • Patients with infected wounds
  • Full thickness skin wounds located in face and/or genitals will not be included
  • Pregnant or breast feeding females
  • Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, uncontrolled diabetes, treatment with corticoid therapy, collagenoses, cancer)
  • Known allergy against porcine collagen or elastin
  • Patients that are expected (according to the responsible medical doctor) to be non-compliant to the study protocol. (This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
  • Previous enrolment of the patient into the current study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie

Berlin, 12683, Germany

Location

Red Cross Hospital

Beverwijk, North Holland, 1942 LE, Netherlands

Location

Children's Hospital Department of Surgery Kinderspital Zurich

Zurich, Switzerland

Location

Related Publications (1)

  • Boekema BK, Vlig M, Olde Damink L, Middelkoop E, Eummelen L, Buhren AV, Ulrich MM. Effect of pore size and cross-linking of a novel collagen-elastin dermal substitute on wound healing. J Mater Sci Mater Med. 2014 Feb;25(2):423-33. doi: 10.1007/s10856-013-5075-2. Epub 2013 Nov 1.

    PMID: 24178984BACKGROUND

Related Links

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Esther Middelkoop, Prof. dr.

    Red Cross Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
participant and assessor are both unaware of location of dermal template
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: part of wound treated with /without dermal template
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2015

First Posted

February 27, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2016

Study Completion

September 1, 2016

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

CH(1)DE(1)NL(1)