CLIMATE - A POTENTIAL CAUSE OF PRIMARY GRAFT FAILURE IN BUCCAL MUCOSAL GRAFT URETHROPLASTY

Abstract

INTRODUCTION AND OBJECTIVE: The purpose of this randomized controlled trial is to determine the impact of closure versus non-closure of the buccal mucosal graft harvest site in men undergoing urethral reconstruction. The primary endpoint was postoperative oral pain. Secondary endpoints were time to return to regular diet, oral numbness, change in salivation, and time to full mouth opening. METHODS: Fifty consecutive patients have been randomized to either closure of the donor site or leaving the donor site open. All procedures were performed by one surgeon (KR). Postoperatively, questionnaires were completed daily for the first week and monthly for 6 months. The questionnaire consisted of a visual analog pain scale, as well as questions pertaining to return to regular diet, salivation, numbness, and ability to fully open mouth. Independent samples T-test and Chi-square analysis was performed on continuous and categorical data, respectively. RESULTS: Twenty-four and 26 patients were randomized to the open and closed groups. The mean ages were similar, 44 in the open and 43 in the closed group. There were no infectious or bleeding complications in either group. One patient in the closed group reported a change in denture fit post operatively. Post operative pain demonstrated a trend favoring the open group at postoperative day one (4.1 vs 2.2 p=0.07). At 6 months, there was no difference in pain scores between groups (0.2 vs 0.3 p=0.63). Return to regular diet was sooner for the open group at postoperative day one (69 vs 31 % p=0.01). At 6 months, all patients were tolerating regular diet. Numbness at harvest site was present in 62% open versus 93% closed (p=0.05) patients postoperative day one. At 6 months, 20% open vs 40% closed patients (p=0.15) reported persistent oral numbness. Salivary changes did not differ between groups at either time point. Full mouth opening at postoperative day one was reported by 77% open and 14% closed (p=0.001). At 6 months, 10% open and 8% closed reported a decrease in full mouth opening since surgery (p=0.81). CONCLUSIONS: The data from our randomized controlled trial suggest that leaving the buccal mucosa harvest site open may lead to lower reported pain scores, earlier return to full diet, and earlier return to full mouth opening. At the 6 months endpoint there may be a decrease in harvest site numbness for patients in the open group.