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?
Who is the main contact?
Comparison of enzymatic, mechanical and autolytic debridement methods efficiencies for the treatment of the forearm and hand deep dermal burns
EMANAM (Enzymatic, Mechanical and Autolytic Necrectomy for Ambustum Manus)
To compare enzymatic, mechanical and autolytic debridement methods for treatment of the forearm and hand deep dermal partial thickness burns.
Kaunas regional biomedical research ethics committee, 07/01/2014
Randomized controlled parallel-group single-center clinical trial
Primary study design
Secondary study design
Randomised parallel trial
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Forearm and hand deep dermal partial thickness burns
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.
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
Overall trial end date
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
Target number of participants
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
Recruitment end date
Countries of recruitment
Trial participating centre
Lithuanian University of Health Sciences Kaunas Clinics
Department of Plastic and Reconstructive Surgery Eiveniu st. 2
Funding Body Type
Funding Body Subtype
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
(firstname.lastname@example.org) on reasonable request
Intention to publish date
Participant level data
Available on request
Results - basic reporting