OBJECTIVE: The objective of this study is to test the hypothesis that using a simple and inexpensive preoperative tissue expansion device for radial forearm free flap donor sites will result in a significant reduction in healing time and reduced postoperative pain compared to unexpanded radial forearm free flap donor site skin. METHODS:Twenty-nine patients were enrolled and randomized to either the treatment (tissue pre-expansion) or the control group. An intention-to-treat analysis was used. Healing time was recorded for all patients. The Short Form McGill Pain Questionnaire was used to record arm pain and overall surgical pain 1 week postsurgery. RESULTS: The mean (95% CI) healing time was 5.7 (3.9-7.6) days for the treatment group and 32.5 (12.2-53.0) days for the control group (p < .001). Overall surgical pain (p < .001) was significantly lower in the treatment group. There was no significant difference in donor site arm pain (p < .2). CONCLUSION: Using a simple, noninvasive method of preoperative tissue expansion results in both clinically and statistically significant reductions in healing time and postoperative pain.
RCT Entities:
OBJECTIVE: The objective of this study is to test the hypothesis that using a simple and inexpensive preoperative tissue expansion device for radial forearm free flap donor sites will result in a significant reduction in healing time and reduced postoperative pain compared to unexpanded radial forearm free flap donor site skin. METHODS: Twenty-nine patients were enrolled and randomized to either the treatment (tissue pre-expansion) or the control group. An intention-to-treat analysis was used. Healing time was recorded for all patients. The Short Form McGill Pain Questionnaire was used to record arm pain and overall surgical pain 1 week postsurgery. RESULTS: The mean (95% CI) healing time was 5.7 (3.9-7.6) days for the treatment group and 32.5 (12.2-53.0) days for the control group (p < .001). Overall surgical pain (p < .001) was significantly lower in the treatment group. There was no significant difference in donor site arm pain (p < .2). CONCLUSION: Using a simple, noninvasive method of preoperative tissue expansion results in both clinically and statistically significant reductions in healing time and postoperative pain.