A Prospective, Descriptive Cohort Study With Prontosan® Wound Gel X in Partial and Full Thickness Burns Requiring Split Thickness Skin Grafts

NCT01534858 | Completed

• 1 other identifier: OPM-O-H-1102
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the healing of split thickness skin grafts when treated with Prontosan® Wound Gel X in patients with partial and full thickness skin burns.

Conditions

Burns

Keywords

polyhexanide, polihexanide, PHMB, Prontosan, burns, wounds

Outcome Measures

Primary Outcomes (4)

• Graft neo-epithelisation

  29 days

• Time to complete epithelization

  29 days

• Wound infection

  29 days

• Need for re-operation of target wound site

  29 days

Secondary Outcomes (3)

• Pain

  29 days

• Pruritis

  29 days

• Erythema

  29 days

Study Arms (1)

Partial and full thickness burns with split thickness grafts

EXPERIMENTAL

Device: Prontosan Wound Gel X

Interventions

Prontosan Wound Gel X DEVICE

Prontasan Wound Gel X will be applied topically as a thin layer to the entire grafted area immediately after transplant and with each dressing change.

Also known as: polihexanide and betaine containing hydrogel

Partial and full thickness burns with split thickness grafts

Eligibility Criteria

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

You may qualify if:

• Partial of full thickness burns requiring split thickness grafts
• Target burn wound size 10cm2-1000cm2
• Age ≥ 18 years
• Ability to read, write and speak German.
• Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent approved by the Institutional Ethics Committee (IEC) prior to all evaluations. Informed consent will be obtained from the patient or by a legal representative if the patient is not able/competent to consent. In this case, informed consent will be also obtained by the patient when he/she regains competence.
• Women of child bearing potential must test negative on standard urine pregnancy test and must agree to practice appropriate contraceptive methods for the duration of the study (e. g. oral contraceptive, IUD, intra-muscular contraceptive, abstinence).

You may not qualify if:

• Target wound has exposed hyaline cartilage
• Connective tissue disorder
• Previous skin graft failure at target wound site
• Total burn surface area ≥ 70%
• Infected target wound
• Immunosuppression therapy
• Chronic hemodialysis
• Steroid use
• Diabetes (Type I)
• Allergy or sensitivity to any of the ingredients in Prontosan® Wound Gel X
• Allergy or sensitivity to chlorhexidine
• Pregnancy
• Simultaneous participation in another clinical trial

Sponsors & Collaborators

• B. Braun Ltd. Centre of Excellence Infection Control: lead

Study Sites (3)

Berufsgenossenschaftliche Unfallklinik Ludwigshafen

Ludwigshafen, Baden-Wurttemberg, 67071, Germany

Location

Berufsgenossenschaftliches Unfallklinikum Bergmannsheil

Bochum, 44789, Germany

Location

Klinikum St. Georg

Leipzig, 44129, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Burns; Wounds and Injuries

Study Officials

• Adrien Daigeler, Prof.

  Berufsgenossenschaftliches Unfallklinikum Bergmannsheil Bochum

  PRINCIPAL INVESTIGATOR

• Jurij Kiefer, Dr.

  Berufsgenossenschaftliche Unfallklinik Ludwigshafen

  PRINCIPAL INVESTIGATOR

• Adrian Dragu, PD Dr. med.

  Klinikum St. Georg Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2012
• First Posted: February 17, 2012
• Study Start: March 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 2, 2018

Record last verified: 2015-09

Locations

DE (3)