Overview

Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSH-12)

Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
All
Summary
The main purpose of this phase III clinical trial was to compare intra-individually the efficacy, safety and tolerability of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only in accelerating the wound healing of Split-Thickness Skin Graft (STSG) donor sites.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Birken AG
Criteria
Inclusion Criteria:

- Presenting a split-thickness skin graft donor site wound with a minimum size of 15 cm2
and with a minimum width of 3 cm.

- Patient is able to understand the Informed Consent Form (ICF) provided and is prepared
to comply with all study requirements, including the following: Visiting the trial
site for wound dressing change and photo documentation every third or fourth day until
both wound halves are closed (but no longer than 28 days after surgery).

- Willing to perform all necessary wound dressing changes at the trial site. Also the
patient needs to agree to return to site for 3 and 12 months follow-up visits.

- Women of childbearing potential must apply highly effective method of birth control
(failure rate less than 1% per year when used consistently and correctly (e.g.,
implants, injectables, combined oral contraceptives, some intrauterine contraceptive
devices (IUDs), sexual abstinence, or a vasectomized partner)).

Exclusion Criteria:

- Diseases or conditions that could, in the opinion of the Investigator, interfere with
the assessment of safety or efficacy.

- A skin disorder that is chronic or currently active and which the Investigator
considers will adversely affect the healing of the acute wounds or involves the areas
to be examined in this trial.

- A history of clinically significant hypersensitivity to any of the drugs, surgical
dressings or excipients to be used in this trial.

- Known multiple allergic disorders.

- Taking, or have taken, any investigational drugs within 3 months prior to the
screening visit.

- Pregnant or breast feeding women are not allowed to participate in the study.

- Inappropriate to participate in the study, for any reason, in the opinion of the
investigator.

- Mental incapacity or language barriers precluding adequate understanding the Informed
consent form or co-operation or willingness to follow study procedures.

- Previous participation in this study.

- Employee at the investigational site, relative or spouse of the investigator.