Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 Versus Moist Wound Healing Dressing Alone in Accelerating the Epithelialization of Split Thickness Skin Graft Donor Sites

NCT01294254 | Completed Phase 2

• 1 other identifier: BSH-10
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

In this study the wound reepithelialization of that part of the skin graft donor site, which is treated with Oleogel-S10 compared to that part of the wound, which is covered by moist wound healing dressing alone will be investigated.

Conditions

Accelerating the Epithelialization of Split Thickness Skin Graft

Keywords

wound reepithelialization

Outcome Measures

Primary Outcomes (1)

• Wound reepithelialization of that part of the skin graft donor site, which is treated with Oleogel-S10 compared to that part of the wound, which is covered by moist wound healing dressing alone during a treatment period of 14 days.

  14 days

Secondary Outcomes (4)

• • Size of wound epithelialization

  3 months

• • Touch sensitivity: Sensitivity of the SSG wound by touching it with a spatula or cotton swabs (visual analogue scale from "no" = 0 to "severe" = "10"

  3 months

• • Pruritus (visual analogue scale from "no" = 0 to "strong" = "10")

  3 months

• • Reconstitution of the skin (% reepithelization) 3 months after skin explantation

  3 months

Study Arms (2)

experimantal: wound site will be treated with Oleogel-S10

EXPERIMENTAL

The patients will be randomised in a ratio of 1:1 with regard to the part of the skin graft donor site that is treated with Oleogel-S10. Arm A: application of Oleogel-S10 towards the periphery of the body, i.e. the lower part of the leg Arm B: application of Oleogel-S10 towards the centre part of the body, i.e. the upper part of the leg * Oleogel-S10 on one half of the skin graft donor site (each time when the wound dressing is changed during a time period of 14 days, normally once daily) * Moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor site

Drug: Oleogel-S10

Moist wound healing dressing alone

ACTIVE COMPARATOR

Treatment with moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor site

Procedure: Moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor site

Interventions

Oleogel-S10 DRUG

Oleogel-S10 on one half of the skin graft donor site (each time when the wound dressing is changed during a time period of 14 days, normally once daily)

experimantal: wound site will be treated with Oleogel-S10

Moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor site PROCEDURE

wound is covered conventionally by applying one half of the Mepilex cut

Moist wound healing dressing alone

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may participate in the study if they have/are
• Patients aged 18-95 years who have provided written informed consent.
• Patients requiring skin grafting due to burns, trauma, chronic venous ulcers, or surgical removal of cutaneous malignancies with a donor site expected to be between 8 and 200 cm2 on a non-articulated area.
• Patient is prepared to comply with all study requirements, including the following:
• Application of Oleogel-S10 on the SSG at every change of wound dressing;
• Regular clinic visits during the treatment period, and follow-up period.
• Negative pregnancy test of women of childbearing potential performed within 7 days prior to the start of treatment.
• Women of childbearing potential must agree to use an effective method of contraception (Pearl-Index \< 1, e.g. hormonal contraception including the combined oral contraceptive pill, the transdermal patch, and the contraceptive vaginal ring, intrauterine devices or sterilization) during treatment and for at least 6 months thereafter.
• Men must agree to use an effective method of contraception during treatment and for at least 6 months thereafter.

You may not qualify if:

• Patients will be excluded from the study if they have/are
• burns involving more than 15% of their total body area;
• sepsis, haemodynamic instability requiring pressor support or positive blood microbiology cultures within 48h of surgery;
• inhalation injury requiring artificial respiratory assistance;
• requiring skin grafts following removal of suspicious skin lesions;
• received treatment with systemic steroids during the 30 days prior to surgery;
• uncontrolled diabetes or diabetic ulcers;
• diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerance or efficacy;
• previously skin grafts harvested from the area to be studied;
• 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 or surgical dressings 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;
• undergoing investigations or changes in management for an existing medical condition;
• not likely to complete the trial for whatever reason.

Sponsors & Collaborators

• Birken AG: lead

Study Sites (2)

Universitäts-Hautklinik Freiburg

Freiburg im Breisgau, 79104, Germany

Location

Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald

Greifswald, 17475, Germany

Location

Related Publications (1)

• Metelmann HR, Brandner JM, Schumann H, Bross F, Fimmers R, Bottger K, Scheffler A, Podmelle F. Accelerated reepithelialization by triterpenes: proof of concept in the healing of surgical skin lesions. Skin Pharmacol Physiol. 2015;28(1):1-11. doi: 10.1159/000357501. Epub 2014 Jul 15.

  PMID: 25034442 RESULT

Study Officials

• Hans Robert Metelmann, Prof. Dr. med.

  University Hospital of Ernst-Moritz-Arndt-University Greifswald

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2010
• First Posted: February 11, 2011
• Study Start: April 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: April 3, 2015

Record last verified: 2015-04

Locations

DE (2)