CompletedPhase 4ACTRN12617001058369

Comparative study of outcome of Topical steroid application compared with traditional dressing for non healing wound in burn patients,

Efficacy of topical steroid in treatment of hyper granulation tissue in burn patients: A randomized control trial


Sponsor

Farrukh Aslam Khalid

Enrollment

32 participants

Start Date

Jul 24, 2017

Study Type

Interventional

Conditions

Summary

After getting approval from the ethical committee of our hospital .Total 32 patients who fulfill our inclusion criteria will be enrolled in our study. An inform consent will be taken from each patient. All cases will underwent surgical debridement and split thickness skin grafting. We will randomized select the patients into two groups with secondarily graft loss area less than 5cm2 by lottery method. In Group A, we will apply Topical 1% Hydrocortisone (Fusidin-H cream) and Group B will be managed with Medicated Paraffin gauze (bactigrass) dressing. Steroid will be applied topically thinly smeared once daily with 4x4 inch gauze piece onto wound bed. We will observe and access the wound weekly with visual and photographic evaluation that will be done by two consultant plastic surgeons. During the dressing changes, routine digital photographs will be taken with the signed consent of the patient/guardian for the purposes of treatment, teaching and use in academic publications. Time to complete wound healing was noted and defined as the number of days from application of steroid until epithelialization. Percentage of total body surface area burned, sex, age, burn mechanism, complications (burning skin, dry skin, and itching, increased hair growth at application site) and presence of hyper granulation tissue were assessed and correlated with time to complete wound healing.


Eligibility

Sex: Both males and femalesMin Age: 13 YearssMax Age: 50 Yearss

Inclusion Criteria1

  • Non healing wound < 5 cm(square) in burn patients due to split skin graft loss

Exclusion Criteria4

  • Sepsis
  • Culture positive wounds
  • Pregnancy
  • Patients is on steroids (immunocompromised)

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Interventions

In Group A we will apply Topical 1% Hydrocortisone (Fusidin-H cream) thinly smeared once daily with 4x4 inch gauze piece onto wound bed by the dresser. Primary researcher will follow the patient for

In Group A we will apply Topical 1% Hydrocortisone (Fusidin-H cream) thinly smeared once daily with 4x4 inch gauze piece onto wound bed by the dresser. Primary researcher will follow the patient for intervention adherence and will note in data. During the dressing changes, routine digital photographs will be taken. Duration of treatment will be till the wound healed (epithelialized). Time to complete wound healing will be noted and defined as the number of days from application of steroid until complete epithelialization.


Locations(1)

Punjab, Pakistan

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