OBJECTIVE:Patients with tympanic membrane (TM) perforations often have infections, and repetitive topical treatment may be required. These infections can be prevented by permanent closure of the TM perforation. Different surgical treatment options have been described, but noninvasive techniques may be preferred as they carry less risk than surgery. One noninvasive approach is to induce wound healing by application of growth factors. The effect and clinical use of applying topical platelet-derived growth factor (PDGF) for decrease of size and closure of chronic TM perforations is evaluated. STUDY DESIGN: Prospective, randomized, placebo-controlled, double-blind study. SETTING: Tertiary referral center. PATIENTS: Twenty patients with chronic suppurative otitis media without cholesteatoma for more than 3 months. INTERVENTION: Topical treatment with PDGF or placebo applied weekly to the TM for 6 weeks. MAIN OUTCOME MEASURES: Success rate, defined as a reduction of perforation size of 50% or more to determine relative changes of the perforation size; effect of initial size and location of TM perforation on success rate; and air and bone conduction thresholds to determine air-bone gap measured before treatment. RESULTS: Randomization made matching pretreatment perforation size of the 2 study groups impossible, and the initial rate perforation/TM was significantly smaller in the PDGF group. No difference between the 2 groups was found for perforation/TM less than 10%. However, success rate did not differ significantly between the 2 groups (power = 0.8), and the effect of PDGF was found to be small (-2%; standard deviation, ±49%). Initial size and position of the TM perforation were not significant factors determining success. Mean air-bone gap for the frequencies of 0.5, 1, 2, and 4 kHz was 22.5 dB. CONCLUSION: The topical application of PDGF as an office treatment for chronic otitis media is not a favorable alternative to surgery.
RCT Entities:
OBJECTIVE:Patients with tympanic membrane (TM) perforations often have infections, and repetitive topical treatment may be required. These infections can be prevented by permanent closure of the TM perforation. Different surgical treatment options have been described, but noninvasive techniques may be preferred as they carry less risk than surgery. One noninvasive approach is to induce wound healing by application of growth factors. The effect and clinical use of applying topical platelet-derived growth factor (PDGF) for decrease of size and closure of chronic TM perforations is evaluated. STUDY DESIGN: Prospective, randomized, placebo-controlled, double-blind study. SETTING: Tertiary referral center. PATIENTS: Twenty patients with chronic suppurative otitis media without cholesteatoma for more than 3 months. INTERVENTION: Topical treatment with PDGF or placebo applied weekly to the TM for 6 weeks. MAIN OUTCOME MEASURES: Success rate, defined as a reduction of perforation size of 50% or more to determine relative changes of the perforation size; effect of initial size and location of TM perforation on success rate; and air and bone conduction thresholds to determine air-bone gap measured before treatment. RESULTS: Randomization made matching pretreatment perforation size of the 2 study groups impossible, and the initial rate perforation/TM was significantly smaller in the PDGF group. No difference between the 2 groups was found for perforation/TM less than 10%. However, success rate did not differ significantly between the 2 groups (power = 0.8), and the effect of PDGF was found to be small (-2%; standard deviation, ±49%). Initial size and position of the TM perforation were not significant factors determining success. Mean air-bone gap for the frequencies of 0.5, 1, 2, and 4 kHz was 22.5 dB. CONCLUSION: The topical application of PDGF as an office treatment for chronic otitis media is not a favorable alternative to surgery.
Authors: Peter Luke Santa Maria; Peter Gottlieb; Chloe Santa Maria; Sungwoo Kim; Sunil Puria; Yunzhi Peter Yang Journal: Tissue Eng Part A Date: 2017-02-24 Impact factor: 3.845