Wound Healing Complication Clinical Trial
Official title:
Effect of Topically-Applied Hyaluronic-Acid on Palatal Epithelial Wound Closure
Aim of the study is to assess the therapeutic effects of topical hyaluronic-acid use on secondary wound healing of the free gingival graft donor site. The hypothesis of this study is that topical hyaluronic-acid gel has positive effects on secondary wound healing of free gingival graft donor site by reducing pain, burning sensation, and accelerating the healing.
The objective of the randomized, single blind, controlled and parallel clinical trial was to
assess therapeutic effects of topical hyaluronic-acid on secondary wound healing of free
gingival graft donor site.
Primary outcome variables that pain and burning sensation changes were assessed at 3, 7, 14,
21 days after surgery by the examiner. Pain and burning sensation were assessed by patients
using the VAS, score 0 indicate no pain or burning sensation, score 10 indicate severe pain
or burning sensation. Secondary outcome variables included color match, consistency and
epithelization of the wound area. These parameters were assessed by the same examiner at 3,
7, 14, 21 and 42 days after surgery. Color of the palatal mucosa was assessed by comparing
it to that of the adjacent and opposite site using the VAS. Score 0 indicate no color match
and score 10 indicate very good color match. Consistency of the palatal mucosa was assessed
with a blunt instrumentation and scored as soft or firm. Epithelialization was scored
clinically as none, partial or complete.
Sample size has been estimated in 12 subjects per treatment groups. Random allocation of the
treatment sites to test and control groups will be performed using a computerized selection
of random numbers for allocation of the study groups.
Clinical images obtained at baseline, 3, 7, 14, 21 and 42 days after surgery from each
treatment site.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03010137 -
Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial
|
N/A |