Peter Langford1, Rory Wolfe, R Andrew Danks. 1. Department of Neurosciences, Monash Medical Centre, Monash University, Melbourne, Australia. rhlangford@internode.on.net.
Abstract
OBJECT: In this prospective randomized clinical trial, investigators looked at wound healing after craniotomy. The hypothesis was that the self-closing plastic scalp clips used for hemostasis on the skin edge might lead to localized microscopic tissue damage and subsequent delayed wound healing. METHODS: The trial consisted of 2 arms in which different methods were used to secure scalp hemostasis: 1) the routinely used plastic clips (Scalpfix, Aesculap); and 2) the older method of artery forceps placed on the galea. Participants were restricted to those > 16 years of age undergoing craniotomies expected to last > 2 hours. Repeat operations were not included. One hundred fifty patients were enrolled. They were visited at 3 and 6 weeks postoperatively by an observer blinded to the method used, and the wounds were assessed for macroscopic epithelial closure, signs of infection, and hair regrowth by using a predefined assessment scale. RESULTS: The results showed no significant difference in wound healing between the 2 groups at either 3 weeks (OR 0.55, 95% CI 0.27-1.11; p = 0.09) or 6 weeks (OR 0.79, 95% CI 0.39-1.58; p = 0.50). The length of operation was found to be a significant factor affecting wound healing at 6 weeks (OR/hour 0.68, 95% CI 0.51-0.92; p = 0.01). CONCLUSIONS: The use of Aesculap Scalpfix self-retaining plastic scalp clips on the skin edge during craniotomy surgery does not appear to affect wound healing significantly to the postoperative 6-week mark.
RCT Entities:
OBJECT: In this prospective randomized clinical trial, investigators looked at wound healing after craniotomy. The hypothesis was that the self-closing plastic scalp clips used for hemostasis on the skin edge might lead to localized microscopic tissue damage and subsequent delayed wound healing. METHODS: The trial consisted of 2 arms in which different methods were used to secure scalp hemostasis: 1) the routinely used plastic clips (Scalpfix, Aesculap); and 2) the older method of artery forceps placed on the galea. Participants were restricted to those > 16 years of age undergoing craniotomies expected to last > 2 hours. Repeat operations were not included. One hundred fifty patients were enrolled. They were visited at 3 and 6 weeks postoperatively by an observer blinded to the method used, and the wounds were assessed for macroscopic epithelial closure, signs of infection, and hair regrowth by using a predefined assessment scale. RESULTS: The results showed no significant difference in wound healing between the 2 groups at either 3 weeks (OR 0.55, 95% CI 0.27-1.11; p = 0.09) or 6 weeks (OR 0.79, 95% CI 0.39-1.58; p = 0.50). The length of operation was found to be a significant factor affecting wound healing at 6 weeks (OR/hour 0.68, 95% CI 0.51-0.92; p = 0.01). CONCLUSIONS: The use of Aesculap Scalpfix self-retaining plastic scalp clips on the skin edge during craniotomy surgery does not appear to affect wound healing significantly to the postoperative 6-week mark.