Influencing Wound Healing Through the Application of Hyaluronic Acid With Perfluorodecalin and Physalis Angulata Extract After Split Skin Removal From the Thigh - A Study in "Split Wound Design"

NCT ID: NCT03668665

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-31
• Study Completion Date: 2020-10-31

Brief Summary

The study will use a split wound design to investigate whether secondary wound healing can be accelerated and improved by the application of hyaluronic acid combined with perfluorodecalin and Physalis angulata extract.

Detailed Description

In oral and maxillofacial surgery, split skin is regularly removed to cover secondary defects. These defects occur, for example, in tumor patients after the removal of microsurgical radialis or fibular grafts for defect coverage or reconstruction, since the skin cannot be primarily closed there.

Split skin is defined as a free skin graft made of epidermis and the upper parts of the dermis. The average thickness of the grafts is 0.2-0.8 mm. The thickness of the split skin determines the pigmentation structure and the quality of the graft. The thinner the split skin, the better the healing tendency and the less scar remains at the donor site. However, a disadvantage of thin split skin grafts is the stronger secondary shrinkage in the recipient region. Moderately thick grafts are hardly subject to scar shrinkage, but occasionally leave hypertrophic scars or keloids at the donor site. Split skin grafts with a thickness of 0.6-0.8 mm provide the best esthetic results, but have a poorer healing rate.

The split skin can be removed with a dermatome. The ventrolateral proximal thighs and the inside and outside of the upper arms are particularly suitable as donor regions.

In oral and maxillofacial surgery, a 0.4 mm thick split skin is usually removed from the ventrolateral thigh to cover the defect in the forearm or lower leg.

The requirement at the split skin removal site is rapid healing with complete re-epithelialization. To achieve this, wound management is currently left to the clinic itself, as there is no evidence-based standard care. The technical literature only recommends moist wound management and rare dressing changes.

A new product that promises faster healing and reduced scarring of these wounds is Ready Medical Post Treatment. This is an established preparation consisting of hyaluronic acid, perfluorodecalin and Physalis angulata extract. Studies have shown that both hyaluronic acid and perfluorodecalin can significantly improve the epithelialisation rate of wounds. The study will use a split wound design to investigate whether secondary wound healing can be accelerated and improved by the application of hyaluronic acid combined with perfluorodecalin and Physalis angulata extract.

Conditions

Wound Heal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Conventionell Treatment

After split skin removal, the wound is divided into 2 parts (=2 arms):

1st half: conventional treatment with moist dressings (mepilex and fixomull)

Group Type: ACTIVE_COMPARATOR

Conventionell Treatment

Intervention Type: DEVICE

Treatment of half of the wound with conventional moist dressings (Mepilex and Fixomull); a dressing change only takes place on the 7th day postoperatively

Treatment with Ready Medical Post Treatment

After split skin removal, the wound is divided into 2 parts (=2 arms):

2nd half: conventional treatment with moist dressings (mepilex and fixomull) and additional treatment with ready medical post treatment

Group Type: EXPERIMENTAL

Ready Medical Post Treatment

Intervention Type: DRUG

Treatment of half of the wound with the product "ready medical post treatment" in addition to conventional treatment with moist dressings (Mepilex and Fixomull); on the 1st, 4th and 7th day after surgery, the product is applied to the wound and the dressing is changed

Interventions

Ready Medical Post Treatment

Treatment of half of the wound with the product "ready medical post treatment" in addition to conventional treatment with moist dressings (Mepilex and Fixomull); on the 1st, 4th and 7th day after surgery, the product is applied to the wound and the dressing is changed

Intervention Type: DRUG

Conventionell Treatment

Treatment of half of the wound with conventional moist dressings (Mepilex and Fixomull); a dressing change only takes place on the 7th day postoperatively

Intervention Type: DEVICE

Other Intervention Names

Hyaluronic acid combined with perfluorodecalin and Physalis angulata extract; Wound treatment with moist dressings

Eligibility Criteria

Inclusion Criteria

• Age between 18-90 years
• Split skin removal at the thigh must be planned for the patients
• Adult patients who are mentally and physically able to understand the importance and scope of the study and to follow up the study staff
• Written informed consent before participating in the study

Exclusion Criteria

• Patients suffering from a systemic disease (e.g. diabetes mellitus, anticoagulant therapy,...)
• Patients taking immunosuppressive drugs that may affect wound healing
• Patients suffering from skin diseases
• Pregnant and/or lactating women. Women of childbearing age should protect themselves from potential pregnancy by adequate contraception while participating in studies.
• Participation in a study may, at the investigator's discretion, present an unacceptable risk due to pre- or concomitant disease or the patient's general underlying condition.
• Underage, or older than 90 years
• Life span is less than six months
• There is a current or past medically relevant disease or treatment that could influence the evaluation of the study
• The patient has received a study medication within the last 30 days as part of another study
• Simultaneous participation in another clinical intervention study
• Expected lack of compliance
• Alcohol or drug abuse
• The patient is accommodated in an institution by official or court order
• Patients in a dependent relationship or employment relationship with the sponsor, investigator, or alternate investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of oral and maxillofacial surgery, University Hospital RWTH Aachen Aachen

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

18-068

Identifier Type: -

Identifier Source: org_study_id