Condition category
Injury, Occupational Diseases, Poisoning
Date applied
12/12/2016
Date assigned
16/12/2016
Last edited
16/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Debridement is the medical removal of dead, damaged, or infected tissue to improve the healing potential of the remaining healthy tissue. Many studies show that debridement is essential for the proper wound healing process. Leaving necrosis (dead tissue) and debris in the wound can lead to the wound not healing and becoming chronic. Many studies demonstrate the advantage of early surgical debridement and grafting (transplantation of skin). Surgical removal of dead tissue of partial thickness burns, especially in the forearm and hand regions, should be performed extremely carefully. Moreover, surgery reduces the chances of the burn wound healing itself (self-epithelialization) and has a high risk of serious complications (massive bleeding, damage to blood vessels and nerves). The aim of this study is to compare non-surgical debridement methods for the treatment of forearm and hand partial thickness burns.

Who can participate?
Patients aged from 18 to 65 with forearm and hand deep dermal partial thickness burns (a burn that affects the top two layers of skin)

What does the study involve?
Participants are randomly allocated into four groups. The first group receives standard treatment with gauze dressings with silver sulfadiazine ointment. The second group is treated with hydrocolloid dressings which promotes the shedding of dead tissues (autolytic debridement). The third group is treated with dressings with silver sulfadiazine cream and mechanical debridement (physically removing dead tissue) with special single-use pads. The fourth group is treated with an enzyme gel on gauze dressings to remove dead tissue (enzymatic debridement). The duration of all treatments is three weeks (21 days). An assessment is organized after six months to assess scarring.

What are the possible benefits and risks of participating?
Participants receive modern non-surgical treatment methods that are less painful and more convenient. Some burn wounds could heal after three weeks. Burn wounds which take longer than 21 days to heal may scar.

Where is the study run from?
Lithuanian University of Health Sciences Kaunas Clinics (Lithuania)

When is the study starting and how long is it expected to run for?
April 2014 to February 2017

Who is funding the study?
Biocentras (Lithuania)

Who is the main contact?
Ernest Zacharevskij
ernest.zacharevskij@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ernest Zacharevskij

ORCID ID

http://orcid.org/0000-0002-7827-1041

Contact details

Eiveniu str. 2
Kaunas
LT-50009
Lithuania
+370 (0)657 74889
ernest.zacharevskij@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FMAN-01

Study information

Scientific title

Comparison of enzymatic, mechanical and autolytic debridement methods efficiencies for the treatment of the forearm and hand deep dermal burns

Acronym

EMANAM (Enzymatic, Mechanical and Autolytic Necrectomy for Ambustum Manus)

Study hypothesis

To compare enzymatic, mechanical and autolytic debridement methods for treatment of the forearm and hand deep dermal partial thickness burns.

Ethics approval

Kaunas regional biomedical research ethics committee, 07/01/2014

Study design

Randomized controlled parallel-group single-center clinical trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Forearm and hand deep dermal partial thickness burns

Intervention

Participants are randomised into four treatment groups:
1. Standard treatment – gauze dressings with silver sulfadiazine (SSD) 1% ointment (Sulfargin, Grindeks AS, LV) applied once daily on burn wounds
2. Hydrocolloid dressings (GranuFlex®, ConvaTec, USA) changed every 3 days which promote autolytic debridement
3. Dressings with silver sulfadiazine 1% cream once daily and mechanical debridement with special single-use pad of monofilament polyester fibers (Debrisoft, Lohmann & Rauscher GmbH & Co, G,A) for the first four to five days once daily
4. Proteolytic enzyme complex gel (Streptomyces flavus 197 Ferment, Biocentras, LTU) on gauze dressings once daily
The duration of all treatments was three weeks (21 days). If this process overstepped 21 days, late grafting would be intended to heal residual parts of the wound. An assessment was organized after six months to evaluate post-burn scars.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Measured at 3, 7, 14 and 21 days post burn:
1. Burn wound size, estimated by covering it with transparent film and counting square centimeters with a ruler
2. Pain, measured with the Visual Analog Scale (VAS) 10 minutes after dressings have been changed
3. Clinical wound conditions: persistence of necrosis, amount of fibrin, granulation tissue, and epithelialization process, evaluated as a percentage from whole wound area by the same physician according to the study protocol measurement parameters
4. Burn wound contamination, assessed using the Levine wound-swabbing technique

Secondary outcome measures

Measured at six months follow-up:
1. Quality of post burn scars, assessed using the Vancouver Scar Scale (VSS)
2. Functional recovery, assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure official Lithuanian translation

Overall trial start date

01/04/2014

Overall trial end date

01/02/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged from 18 to 65
2. Non-extensive burns (total body surface area, TBSA <30%)
3. Forearms and hands deep dermal partial thickness burns (2B°, LDI evaluation: 260 - 600PU)
4. Agreed with trial protocol and signed the consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Patients with superficial partial thickness and full thickness forearms and hands burns (2Aº, 3º; LDI evaluation: <260PU, >600PU)
2. Patients with known pregnancy (pregnancy test was performed for all female patients)
3. Vulnerable persons (psychiatric diagnosis)

Recruitment start date

01/04/2014

Recruitment end date

01/08/2016

Locations

Countries of recruitment

Lithuania

Trial participating centre

Lithuanian University of Health Sciences Kaunas Clinics
Department of Plastic and Reconstructive Surgery Eiveniu st. 2
Kaunas
LT-50009
Lithuania

Sponsor information

Organisation

Biocentras

Sponsor details

Graiciuno str. 10
Vilnius
LT-02241
Lithuania
+370 (0)670 30004
biocentras@biocentras.lt

Sponsor type

Industry

Website

www.biocentras.lt

Funders

Funder type

Industry

Funder name

Biocentras

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

IPD sharing plan
The datasets generated and/or analysed during the current study are available from Ernest Zacharevskij
(ernest.zacharevskij@gmail.com) on reasonable request

Intention to publish date

01/03/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes