Efficacy of silver-ion dressings in accelerating wound healing after hemorrhoidectomy: a dual-center randomized trial
摘要
Hemorrhoids are a prevalent perianal disorder, with surgery being a primary treatment modality. Postoperative wound healing significantly impacts recovery and quality of life. Silver-ion dressings, known for their antimicrobial properties, are a relatively new option, but their efficacy in perianal wound healing is not well-established.
ObjectiveTo determine if silver-ion dressings, compared to petrolatum gauze, accelerate wound healing and improve outcomes following hemorrhoidectomy.
Design, setting, and participantsA dual-center, prospective, randomized clinical trial was conducted from March 2021 to April 2022 at The Fifth Affiliated Hospital of Sun Yat-sen University and Shenzhen Second People’s Hospital. 112 patients undergoing open hemorrhoidectomy were enrolled based on predefined inclusion/exclusion criteria.
InterventionsPatients were randomized 1:1 to either petrolatum gauze covered with woven sterile gauze (Control, n = 50) or silver-ion dressings (Experimental, n = 52). Dressings were changed every 24 h.
Main outcomes and measuresThe primary outcome was time to complete epithelialization. Secondary outcomes included the incidence of wound infection, bacterial culture positivity from wound secretions, pain, wound edema (scored on a 3-point scale: 0 = none, 3 = severe), and dressing usability (using a 4-point scale).
Methods112 patients were enrolled. Participants were randomized to conventional wound care or silver-ion dressing treatment. Postoperative wound healing progression was tracked in both groups, and differences in healing time, pain scores, edema severity, dressing performance, and infection rates were compared. Preoperative and postoperative (day 21 ± 1) blood and urine samples were collected for complete blood count, urinalysis, and liver/kidney function tests to assess safety.
Results102 patients completed the study. The median time to complete epithelialization in the silver ion dressing group (22 days, IQR 21–24.75) was significantly shorter than the control group (29 days, IQR 26.75–32) (P = 0.008). While pain scores were slightly lower in the silver ion group, the difference was not statistically significant (VAS score difference: 0.5, P = 0.766). Anal edema scores were similar between groups (P = 0.619). No postoperative infections occurred. Bacterial culture positivity rates were not significantly different between groups at baseline (P = 0.820) or on postoperative day 14 (P = 0.908). No adverse events were reported in either group.
ConclusionSilver-ion dressings reduce post-hemorrhoidectomy wound healing time versus conventional petrolatum-based dressings, promoting earlier return to work and improved the overall wound dressing experience.
Trial registrationThis study was approved and registered by the Chinese Clinical Trial Center, Registration number: ChiCTR2000039169, Registration time: October 20, 2020 (https://www.chictr.org.cn/).