Trial of Different Wound Dressings in Split-skin Grafted Third Degree Burns

Randomized-controlled Trial of Wound Healing, Pain, Microbiology, Handling and Thrift of Different Wound Dressings in Patients With Split-skin Grafted Third Degree Burns

In plastic and reconstructive surgery, treatment strategies of second-degree burn wounds and split-skin grafted third-degree burn wounds aim at reducing infection and improving reepithelialization. Although previous studies indicate that burn patients benefit from newer wound dressings, only a few studies comparing different wound dressings can be found. Therefore, the aim of this study is to evaluate time to reepithelialization, pain, microbiology, handling and costs of different wound dressings in patients with split-skin grafted third-degree burn wounds.

Study Overview

• Status: Recruiting
• Conditions: Split-skin Grafted Third-degree Burn Wound
• Intervention / Treatment: Device: Silver Nylon dressing; Device: Manuka-Honey; Device: Povidone-Iod (PVP-Iod); Device: Hydrogel

Detailed Description

In the treatment of burn wounds polyhexanide and betaisodona (PVP-Iod) are regularly used today. They act as antiseptics, but both have drawbacks. Polyhexanide evaporates fast and therefore cools patients when applied to a large wound area. Moreover, it is known to reveal a gap for pseudomonas. On the other hand, the half-life of Betaisodona (PVP-Iod) ranges between several minutes and 12 hours. Further, its application causes intense pain, and it is cytotoxic. Other wound dressings involving silver are frequently used, too. However, they color the wounds, which might therefore not be properly assessed. Silver is also thought to be cytotoxic.

New innovations are available today. In wound dressings with bound Silver ions wounds are not colored. Hydrolytic membranes keep the level of acidity low (acidic) and have therefore antiseptic effects that last until epithelialization of a second-degree burn wounds is completed. Medical honey is used in the treatment of chronic wounds and especially in pediatric surgery and oncology. Manuka honey from New Zealand is sterilized before application and is known to be less painful for the patient. Due to its acidic effect, it reduces germ numbers in the wounds. Honey can be left on the wound for more than one day, as well as hydrogel, that is also used for contaminated wounds.

These new wound dressings are just used in a couple of Burn Units for the treatment of second-degree burns or split-skin grafted burns. However, the treatment of large burn wounds with older dressing regimes (e.g. PVP-Iod) cause intensive pain in every dressing change.

Only a few studies pointing at new dressings in burn wounds can be found in the literature. None of them reveals a high quality randomized trial.

The objective of this clinical investigation is a direct comparison of established and newer wound dressings with respect to epithelialization time, pain and the number of pathogenic microbe species. Besides, handling and cost are analyzed.

This is a prospective, randomised, factorial, open clinical study. Endpoint assessment, primarily the time to epithelialization, for direct comparison of the dressings is performed in a blinded way. The aim of this study is to identify the advantages of each dressing.

Every wound dressing will be used in every patient. The order from proximal to distal is varied so that every dressing is at every position in a balanced number of cases and has the same neighbor dressing in a balanced number of cases (Williams-Design). The order is assigned by randomisation. All comparisons of two wound dressing can be made using the same number of paired observations.

Assessors of epithelialization time and germ burden are blinded to the wound dressing used.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reinhard Vonthein, PhD; Phone Number: 00494515002788; Email: vonthein@zks-hl.de
• Study Contact Backup: Name: Tobias Kisch, MD; Phone Number: 00494515003580; Email: tobias.kisch@uni-luebeck.de

Study Locations

• Germany
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Recruiting
      • University of Schleswig-Holstein
      • Contact: Tobias Kisch, MD; Phone Number: 00494515003580; Email: tobias.kisch@uni-luebeck.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Consent-capable male and female patients
• ≥18 years of age
• ≥3% and ≤30% total body surface area (TBSA) split-skin grafted third-degree burn
• appropriate form of wound (not: too small) and localization (not: face, inplane surface)
• ability to asses pain

Exclusion Criteria:

• Immunosuppressive Therapy
• Clinical wound infection
• Allergy against porcine material, bee poison or honey, etherial oil, propyleneglycol, silver, nylon
• Relationship to someone who is involved in the study design or assessment
• Participation in other clinical trials
• Citizen of countries outside Europe

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Device: Silver Nylon dressing; 1/4 of a split-skin grafted third-degree burn wound in a Group (n=20): Consent-capable male and female patients ≥18 years of age who have a split-skin grafted third-degree burn on ≥3% and ≤30% of the surface of the body.	Device: Silver Nylon dressing; Non-staining Silver Nylon dressing with a permanently plated metallic surface on split-skin grafted third-degree burn wound
Active Comparator: Device: Manuka-Honey; 1/4 of a split-skin grafted third-degree burn wound in a Group (n=20): Consent-capable male and female patients ≥18 years of age who have a split-skin grafted third-degree burn on ≥3% and ≤30% of the surface of the body.	Device: Manuka-Honey; Manuka-Honey dressing on split-skin grafted third-degree burn wound
Active Comparator: Device: Povidone-Iod (PVP-Iod); 1/4 of a split-skin grafted third-degree burn wound in a Group (n=20): Consent-capable male and female patients ≥18 years of age who have a split-skin grafted third-degree burn on ≥3% and ≤30% of the surface of the body.	Device: Povidone-Iod (PVP-Iod); Povidone-Iod (PVP-Iod) dressing on split-skin grafted third-degree burn wound
Active Comparator: Device: Hydrogel; 1/4 of a split-skin grafted third-degree burn wound in a Group (n=20): Consent-capable male and female patients ≥18 years of age who have a split-skin grafted third-degree burn on ≥3% and ≤30% of the surface of the body.	Device: Hydrogel; Hydrogel dressing on split-skin grafted third-degree burn wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epithelialization	Percent of epithelialized area	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain (on a visual analogue scale 0-10)	Assessed by VAS (visual analogue scale). 0 means no pain, 10 means maximum pain.	through study completion, an average of 1 year
Microbiologic Smear	Assessed by gram staining and count	through study completion, an average of 1 year
Subjective Handling	Assessed by rating scale (0-5)	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Collaborators: University of Luebeck

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: January 28, 2017
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: hydrogel; silver; comparison; honey; burn wound; wound dressing; split-skin; PVP-Iod
• Additional Relevant MeSH Terms: Burns; Wounds and Injuries; Plasma Substitutes; Blood Substitutes; Povidone
• Other Study ID Numbers: 15-145-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO