Evaluation of the efficacy of a Propionibacterium extract gel in wound healing and symptom relief after open excisional hemorrhoidectomy: a randomized clinical study
Abstract
Background: Postoperative symptoms such as pain, burning, and itching are common following open excisional hemorrhoidectomy and are often associated with several factors, including wound healing. This study evaluated the efficacy of Propionibacterium extract gel (PeG) in promoting wound healing and reducing pain, burning, and itching compared to an ointment containing hyaluronic acid and silver sulfadiazine (HA-SSD).
Methods: In this multicenter, phase IV randomized controlled trial, patients undergoing open excisional hemorrhoidectomy were randomly assigned in a 1:1 ratio to receive PeG or HA-SSD. The primary outcome (wound healing) was evaluated on the basis of grade of epithelialization. Secondary outcomes (pain, burning, and itching) were assessed using a 10-point visual analogue scale at baseline and 10, 20, and 40 days postoperatively.
Results: Of the 119 screened patients, 64 (53.78%) received PeG and 55 (46.22%) received HA-SSD. The baseline characteristics were comparable. After 20 days, 46 (75.4%) of the PeG group patients had an epithelialization grade > 50% (vs n = 37, 72.6% of the HA-SSD group; p = 0.02). By day 40, complete wound healing occurred in 52 (85.3%) of the PeG group patients (vs n = 25, 52.1% of the HA-SSD group; p = 0.003). Both treatments reduced postoperative pain over time, with no significant between-group difference (p = 0.24). PeG demonstrated a superior reduction in burning (p = 0.02) and itching (p = 0.001). Patient satisfaction was higher…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 119 participants or records.
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