Amniotic Membrane Dressing Versus Nitrofurazone-impregnated Dressing in the Treatment of Second-degree Burn Wounds

A Randomized Clinical Trial

Jafar Kazemzadeh, MD; Awat Yousefiazar, MSc; Afshin Zahedi, MD

Disclosures

Wounds. 2021;33(8) 

In This Article

Results

Out of 95 patients assessed for eligibility, 8 were excluded (5 for not meeting inclusion criteria, 2 declined, 1 for other reasons); thus, 87 were randomized (45 in the amniotic membrane dressing group and 42 in the nitrofurazone ointment-impregnated gauze group). Of these, 2 in each group declined to continue. One patient in the amniotic membrane group and 2 in the nitrofurazone group needed surgical debridement and were excluded, 4 in the amniotic group and 2 in the nitrofurazone group were lost to follow-up, and 3 in the amniotic membrane group and 1 in the nitrofurazone group were missing data. Ultimately, data for 70 patients (35 in each group) were assessed for the study (Figure).

Figure.

Consolidated standards of reporting trials flow diagram.

No significant difference was noted between groups regarding average burn TBSA involved (the TBSA of the amniotic membrane and nitrofurazone ointment groups were 12.72% ± 8.99% and 12.61% ± 9.44%, respectively; P = .95). Differences in demographic characteristics, including age (range, 15–50 years) and sex, were also not significant (Table 1).

Using VSS, the epithelialization rate of burn wounds on day 7 after beginning treatment was 100% and 77.1% in amniotic membrane and nitrofurazone groups, respectively, reflecting a statistically significant difference (P = .002). At day 14, the epithelialization rate was 100% in both groups.

No adverse events were noted. Wound cultures were taken based on clinician assessment. There was no clinical or laboratory evidence of infection in either of the 2 groups.

On day 1, pain severity reported using VAS was 3.02 ± 0.70 and 3.33 ± 1.29 in the amniotic membrane and nitrofurazone groups, respectively (P = .27). On day 2, pain severity was 2.11 ± 0.19 and 2.65 ± 1.2 in the amniotic membrane and nitrofurazone groups, respectively, indicating a significant difference between the 2 groups (P = .02). There were no reports of pain on assessment days 7, 14, and 30, and as such, no data were available for collection after day 7.

The dressing was changed once a week in the amniotic membrane group based on scientific literature. In the nitrofurazone group, it was changed 7 times daily, on average.

Mean length of hospitalization was 2.94 ± 1.18 days vs 4.14 ± 2.04 days in the amniotic membrane and nitrofurazone dressing groups, respectively (P = .004) (Table 2). Morphine administration level was 3.75 mg ± 1.45 mg and 4.81 mg ± 0.60 mg in the amniotic membrane and nitrofurazone groups, respectively (P = .04).

At day 7, epithelialization rates were significantly different between the amniotic and nitrofurazone groups (35 [100%] vs 27 [77.1%]; P = .002).

On day 14, the mean scarring score was significantly lower in the amniotic membrane group than in the nitrofurazone group (2.02 ± 0.96 vs 3.28 ± 0.85; P = .001) (Table 2). On day 30, the mean scarring score in the amniotic membrane group was lower than that of the nitrofurazone group (0.73 ± 0.82 vs 0.88 ± 0.67), but the difference not significant (P = .39).

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