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IRCT20141218020364N7 IRCT 2018-01-29 Shiraz University of Medical Sciences Early Excision and Skin Grafting versus Delayed Skin Grafting effect on function in hand Deep Burns Effect of early excision and grafting versus delayed excision and grafting on restoring the functionality of deep burn-injured hands 2013-01-01 anticipated 150 Complete https://irct.ir/trial/18063 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: the random drawing of sealed envelopes (Computer-based table of randomization ), Blinding description: The study participants had know two types of common burn injuries treatment, But due to the dressing on the burn wound, they were not aware of the type of treatment we were used for them. The observer who completed the questionnaire did not know the study groups. The original researcher (burn surgeon) was aware of the study groups. The data analyzer was not known from the study groups. The safety committee and data monitoring were aware of the study groups. N/A Deep Hand Burn. Intervention 1: Intervention Group 1 (Early Excision and Skin Grafting (EEG)): In the EEG group, the patients will be operating after being stabilized during the fifth or seventh day after the injury. In the operation room, under the sterile condition and after general anesthesia, upper extremity tourniquet will be used to decrease active bleeding. The dead tissue in deep burn hand skin will be debrided using Goulian knife; then, tissue viability will assess according to the amount of bleeding in the debrided tissues. The debrided area will then cover with a sheet of skin (0.3 mm thickness) and fixe with skin stapler. The dressing will be applied and all of the below mentioned postoperative steps for the DEG group will be used for the EED group. Short splitting will be applied on the hands until the first dressing change. Passive and active hand physiotherapy will start at the end of 7th day. Intervention 2: Intervention Group 2 (Delayed Excision Skin Grafting (DEG)): In the DEG group, the patients will operate after being stabilized (complete granulation tissue formation) after the first 14 days after injury. Daily dressing (twice a day) with topical antibiotics including silver sulfadiazine and mafenide acetate will use under a general surgeon supervision. The infected wound will be treated with intravenous antibiotics according to wound culture and antibiogram. In the operating room with an aseptic setting and under generalized anesthesia, the dead tissue (Scar) will be excised and debrided until reaching a proper bed for skin grafting (viable tissue). The debrided area will then cover with a partial thickness non-meshed (sheet) skin in use from the patient’s healthy skin of the thighs at the same stage. The dressing will then remove on the 5th postoperative day unless signs of infection (such as abnormal discharge, high-grade fever, changes in general condition, etc.) will observe; their dressings will change sooner. Yes - There is a plan to make this available What will be shared: all collected deidentified IPD data could be shared. When: 12 months after publication To whom: people working in academic institutions Conditions: data analysis in the systematic review is provided. Where to obtain: all applicant should call the following number: Mehdi Ayaz; Burn and wound healing research center, Department of Surgery, Division of Burn and Reconstructive Surgery Shiraz University of Medical Sciences Shiraz, Iran. E-mail: ayazmahdi@yahoo.com Postal address: 71339-75121 Tel number: 00989121085896. How to obtain: After contacting the applicant and identifying the university identity and reviewing the application, the information will be e-mailed to him/her within a one-month period of time. Comments:
public Mehdi Ayaz
Fakhrabad Street,
Shiraz Iran (Islamic Republic of) 987163854733 +98 71 3821 9638 ayazm@sums.ac.ir Shiraz University of Medical Sciences scientific Mehdi Ayaz
Fakhrabad Street, Shiraz
Shiraz Iran (Islamic Republic of) 987163854733 +98 71 3821 7090 ayazm@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) ِDeep second and third-degree burns both hand burn with deep second degree burn age limitation of 15-70 years covering less than 50% of total body surface area (TBSA) 15 years 70 years Both elderly patients with comorbidity diseases (diabetes Mellitus, chronic respiratory, cardiac and vascular diseases, hypertension) scars from previous burn injuries having connective tissue disorders burn as a component of multiple trauma significant inhalation injury or need to intensive care Left handed patients less than 10 hand finger burn T23 Burn and corrosion of wrist and hand Treatment - Surgery Treatment - Surgery Intervention Group 1 (Early Excision and Skin Grafting (EEG)): In the EEG group, the patients will be operating after being stabilized during the fifth or seventh day after the injury. In the operation room, under the sterile condition and after general anesthesia, upper extremity tourniquet will be used to decrease active bleeding. The dead tissue in deep burn hand skin will be debrided using Goulian knife; then, tissue viability will assess according to the amount of bleeding in the debrided tissues. The debrided area will then cover with a sheet of skin (0.3 mm thickness) and fixe with skin stapler. The dressing will be applied and all of the below mentioned postoperative steps for the DEG group will be used for the EED group. Short splitting will be applied on the hands until the first dressing change. Passive and active hand physiotherapy will start at the end of 7th day. Intervention Group 2 (Delayed Excision Skin Grafting (DEG)): In the DEG group, the patients will operate after being stabilized (complete granulation tissue formation) after the first 14 days after injury. Daily dressing (twice a day) with topical antibiotics including silver sulfadiazine and mafenide acetate will use under a general surgeon supervision. The infected wound will be treated with intravenous antibiotics according to wound culture and antibiogram. In the operating room with an aseptic setting and under generalized anesthesia, the dead tissue (Scar) will be excised and debrided until reaching a proper bed for skin grafting (viable tissue). The debrided area will then cover with a partial thickness non-meshed (sheet) skin in use from the patient’s healthy skin of the thighs at the same stage. The dressing will then remove on the 5th postoperative day unless signs of infection (such as abnormal discharge, high-grade fever, changes in general condition, etc.) will observe; their dressings will change sooner. Disabilities of hand. Timepoint: Patients were visited weekly in the first month and then every month for the next 3 months. Method of measurement: Direct supervision by the surgeon and completed questionnaire (Michigan hand Q about the function of the hands, ADL, pain, daily activity limitation, scar formation and overall satisfaction in MHQ questionnaire).MHQ questionnaire filled at end of the first and third month. Complication after surgery. Timepoint: 3 month after surgery. Method of measurement: follow up by sergeon. Shiraz University of Medical Sciences Approved 2012-10-31 Ethics committee of Shiraz University of Medical Sciences Fakhrabad Street Shiraz Fars Iran (Islamic Republic of)