Postoperative outcomes after applying Integra dermal regeneration template on pharyngectomized patients: a randomized clinical trial

Abstract

Background: Patients with squamous cell carcinoma of the oral cavity or the oropharynx who undergo a surgical excision, and whose resection is not deep enough to require a reconstruction with a myocutaneous flap, have been usually left to heal by secondary intention. Nevertheless, this results in an unacceptable pain (grades of pain over 50mm in the visual analogue scale (VAS)), long use of nasogastric feeding tube, long hospitalizations and with prolonged dysphagia. M. Tobed and A. Borés have recently developed a new reconstructive technique using Integra® Template (IT®) which aims to improve the postoperative outcomes. Hypothesis and objectives: The reconstruction of the oral cavity and oropharyngeal defects after tumour resections with IT® will improve the postoperative outcomes by mainly reducing the pain. The aim of this study is to register and compare the grade of pain and the outcomes in both techniques (the conventional and IT® reconstruction). Design and setting: This is a randomized, controlled, open-label clinical trial which will be carried out in Hospital Universitari Doctor Josep Trueta from January 2017 until March 2022. Methods: 36 patients, 18 per group, will be needed for the study. They will be recruited using a consecutive non-probabilistic method and they will be randomly assigned to two intervention groups. Those patients who undergo a surgical resection of an oral cavity or oropharyngeal tumour and who do not need a reconstruction using a myocutaneous flap will be offered to enter the study. T-student’s test will be used to prove statistical association between the different techniques and the grade of postoperative pain and a confidence interval of 95% will be assumed. Intervention: The intervention consists on applying IT® over the wound bed once the tumour has been completely resected (intervention group). To do so, Integra® Dermal Regeneration Template 2in x 2in and Ethicon Securestrap™ will be used. The control group will not receive any additional reconstruction after the excision of the tumour and their wound will be left to heal by secondary intention