2.1. Study Design
This study was a randomized split body controlled clinical trial. The study population consisted of all outpatients with superficial partial thickness burns who attended to Shafa hospital burn center, Kerman, Iran.
2.2. Subjects and setting
A convenience sample of 30 patients who had inclusion criteria enrolled in the study. Inclusion criteria were having superficial partial thickness burns with one burn positioned on the one side of the body and the other positioned on the alternate side of the body, total burns less than 20% of the body, each burn surface smaller than 16 cm, no sign of infection and prescribing 2% Nitrofurazone Ointment by Physician, no need for hospitalization, having physician permission to use Aloe Vera Gel instead of 2% Nitrofurazone Ointment, not being affiliated with underlying disease such as diabetes and immune deficiency such as cancer, AIDS and severe skin sensitivity and skin problems, the cause of the burn was contact with heat or hot liquids, admitting to the hospital before 6 hours, no material other than drinking water was used on the wound. in this study, one of the Inclusion criteria is the similarity in total BWAT score in both intervention and control areas. Statistical studies on all BWAT parameters, before the study, shown taht the homogeneity in these areas
Random allocation was done by the study statistician. researcher prepared 30 envelopes containing 15 cards labeled R and 15 cards labeled L. Each Patient selected an envelope. If the envelope with the letter R was opened, interventions would be done on the right side of the body, and vice versa. The other side of the body was treated with 2% Nitrofurazone ointment.
Wounds were washed daily with normal saline 0.9% and dressing with sterile gauze (Sterile gases had no secondary substances) In both intervention and control area a thin layer of gel and ointment was used to cover the whole wound, so about 15 to 20 grams was used based on the wound size. Dressings were changed on a daily basis (according to the routine of the hospital). The burned areas were evaluated for infection each day. Burn wound infection criteria were as detailed by the American Burn Association Consensus Conferences (including Change in color of the burnt area or surrounding skin, Purplish discoloration, mainly if swelling is also present, change in thickness of the burn (the burn suddenly extends deep into the skin), Greenish discharge or pus and Fever. Patients with signs of infection or Systemic Inflammatory Response Syndrome (SIRS) were excluded from the study. Sample recruitment and allocation are presented in figure 1.
The primary outcome in this study achieve a replacement for 2% Nitrofurazone ointment in treatment of superficial partial thickness burns and promotion healing in superficial partial thickness burns.
The Bates–Jensen Wound Assessment Tool (BWAT) was used to evaluate wound healing (35). It is a validated wound assessment tool which is used in many healthcare settings for wound assessment. BWAT is straight forward to use and allows nurses to have an objective, comprehensive assessment of wounds. It consists of 13 items to evaluate wound size, type and depth, amount of necrotic tissue, amount and characteristics of exudate, the presence of granulation tissue, epithelialization, and peri-wound skin. The items and scoring are presented in table 1. Each item is graded on a scale of 1 to 5, where a score of 1 indicates progress toward healing while a score of 5 indicates the absence of healing or wound deterioration. Cumulative BWAT scores vary from 13 to 65 (36). Items and scoring of BWAT are presented in table 1. Two raters (First author and another nurse) scored all wounds simultaneously, the mean of two scores considered as BWAT score. The English version of BWAT has been reported to have good reliability (Cronbach alpha=0.91 and an interrater reliability coefficient of 0.99 (37, 38). Persian version of BWAT was used in previous studies (39), Twenty burns were assessed by two raters separately, and interrater reliability coefficient was 0.89.
Table 1- Items and scoring of Bates-Jensen Wound Assessment Tool
Item
|
1
|
2
|
3
|
4
|
5
|
Size (Length * width)
|
<4 sq cm
|
4--<16 sq cm
|
16.1--<36 sq cm
|
36.1--<80 sq cm
|
>80 sq cm
|
Depth
|
Non-blanchable erythema on intact skin
|
Partial thickness skin loss involving epidermis &/or dermis
|
Full thickness skin loss involving damage or necrosis of subcutaneous tissue; may extend down to but not through underlying fascia; &/or mixed partial & full thickness &/or tissue layers obscured by granulation tissue
|
Obscured by necrosis
|
Full thickness skin loss with extensive destruction, tissue necrosis or damage to muscle, bone or supporting structures
|
Edges
|
Indistinct, diffuse, none clearly visible
|
Distinct, outline clearly visible, attached, even with wound base
|
Well-defined, not attached to wound base
|
Well-defined, not attached to base, rolled under, thickened
|
Well-defined, fibrotic, scarred or hyperkeratotic
|
Undermining
|
None present
|
Undermining < 2 cm in any area
|
Undermining 2-4 cm involving < 50% wound margins
|
Undermining 2-4 cm involving > 50% wound margins
|
Undermining > 4 cm or Tunneling in any area
|
Necrotic Tissue Type
|
None visible
|
White/grey non-viable tissue &/or non-adherent yellow slough
|
Loosely adherent yellow slough
|
Adherent, soft, black eschar
|
Firmly adherent, hard, black eschar
|
Necrotic Tissue Amount
|
None visible
|
< 25% of wound bed covered
|
25% to 50% of wound covered
|
> 50% and < 75% of wound covered
|
75% to 100% of wound covered
|
Exudate Type
|
None
|
Bloody
|
Serosanguineous: thin, watery, pale red/pink
|
Serous: thin, watery, clear
|
Purulent: thin or thick, opaque, tan/yellow, with or without odor
|
Exudate Amount
|
None, dry wound
|
Scant, wound moist but no observable exudate
|
Small
|
Moderate
|
Large
|
Skin Color Surrounding Wound
|
Pink or normal for ethnic area
|
Bright red &/or blanches to touch
|
White or grey pallor or hypopigmented
|
Dark red or purple &/or non-blanchable
|
Black or hyper-pigmented
|
Peripheral Tissue Edema
|
No swelling or edema
|
Non-pitting edema extends <4 cm around wound
|
Non-pitting edema extends >4 cm around wound
|
Pitting edema extends < 4 cm around wound
|
Crepitus and/or pitting edema extends >4 cm around wound
|
Peripheral Tissue Induration
|
None present
|
Induration, < 2 cm around wound
|
Induration 2-4 cm extending < 50% around wound
|
Induration 2-4 cm extending > 50% around wound
|
Induration > 4 cm in any area around wound
|
Granulation Tissue
|
Skin intact or partial thickness wound
|
Bright, beefy red; 75% to 100% of wound filled &/or tissue overgrowth
|
Bright, beefy red; < 75% & > 25% of wound filled
|
Pink, &/or dull, dusky red &/or fills < 25% of wound
|
No granulation tissue present
|
Epithelialization
|
100% wound covered, surface intact
|
75% to <100% wound covered &/or epithelial tissue extends >0.5cm into wound bed
|
0% to <75% wound covered &/or epithelial tissue extends to <0.5cm into wound bed
|
25% to < 50% wound covered
|
< 25% wound covered
|
2.3. Interventions
Aloe Vera gel was extracted as 100% mucilage from the middle part of the Aloe Vera leaf, and sterilized by the Iranian Institute of Medical Plants. The intervention areas dressed with the Aloe Vera gel and the Control areas dressed with 2% Nitrofurazone Ointment. The first author who is a nurse with 5 years of work experience in burn center did all the dressings.
2.4. Statistical Procedures
The data was entered into SPSS Version 16. The BWAT scores and BWAT parameter reported as mean ± SD. The Shapiro-Wilk test was used to test for normality (p>0.05). The change in BWAT scores and BWAT parameter within each area was tested by repeated measure ANOVA. The paired sample t-test was used to compare the BWAT scores and BWAT parameter between two areas before, one, two and three weeks after intervention.