Clinical trial NCT04514263: Oral Biopsies: Evaluation of the Post-surgical Discomfort
Official title: Evaluation of the Post-surgical Discomfort in Patients Undergoing Diagnostic Oral Biopsies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Biopsy Wound
Surgical Wound
Healing Surgical Wounds
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eighty-four patients were enrolled in this study; four of them were excluded because the clinical records were incomplete. Among the 80 patients left, 30 were males and 50 females, with a mean age of 60.25 years (range 23-88); clinical data about remote pathological history were collected: 31/80 patients did not have any systemic diseases, 22/80 only one disease, 27/80 more than one disease; 36/80 patients did not take any drug, 16/80 only one and 28/80 more than one; 63/80 patients did not smoke, 10/80 were former smokers and 7/80 were smokers.

Brief summary: Aim of this study is to evaluate the post-operative course in patients undergoing diagnostic or therapeutic oral mucosal biopsies.

To evaluate the wound healing, all variables connected with the surgery (including post-operative complications) were recorded. To evaluate the psychological and behavioral impact of the post-operative discomfort, two survey tools were administered: OHIP-14 and visual number scale of pain (VNS) were administered at 6h, 7 days and 21 days after biopsy.


Eligibility criteria: Inclusion Criteria:

* no systemic or local contraindications for surgical treatment
* need for an oral biopsy (both excisional and incisional).

Exclusion Criteria:

Since no absolute contraindications to oral biopsies are reported, no exclusion criteria were selected for this study, but if any relative contraindication was present (i.e. bleeding disorders) biopsy was performed after the resolution of the problem

Primary outcomes:
measure: Correlation between the clinical healing and patient perception
timeFrame: Six hours after an oral biopsy
measure: Correlation between the clinical healing and patient perception
timeFrame: One week after an oral biopsy
measure: Correlation between the clinical healing and patient perception
timeFrame: Three weeks after an oral biopsy
Secondary outcomes:
measure: Correlation between OHIP-14 and VNS scale
timeFrame: Six hours after an oral biopsy
measure: Correlation between OHIP-14 and VNS scale
timeFrame: One week after an oral biopsy
measure: Correlation between OHIP-14 and VNS scale
timeFrame: Three weeks after an oral biopsy
measure: Clinical variables which influence the healing and patient perception
timeFrame: Six hours after an oral biopsy
measure: Clinical variables which influence the healing and patient perception
timeFrame: One week after an oral biopsy
measure: Clinical variables which influence the healing and patient perception
timeFrame: Three weeks after an oral biopsy
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of the Sacred Heart
Study officials:
References: