Responses II to reviewer's report / Roland Andersson
Reviewer's report
Title: A prospective randomized controlled multicenter trial comparing antibiotic
therapy (ertapenem) with appendectomy in the treatment of uncomplicated acute
appendicitis (APPAC trial)
Version: 2 Date: 30 October 2012
Reviewer: roland andersson
Reviewer's report:
1. My 4th comment (see below) has not been adequately answered.
4. Wound infection is one of the secondary outcomes. A definition for this is
needed.
The definition of this secondary outcome is added in the text (page 10) as follows:
“Post-intervention data
Surgical treatment
 Clinical wound infection
o Superficial incisional SSI – infection involves only skin and
subcutaneous tissue of incision
o Deep incisional SSI – infection involves deep tissues, such
as fascial and muscle layers
o Organ/space SSI – infection involves any part of the anatomy
in organs and spaces other than the incision, which was
opened or manipulated during the operation”
The clarification on the depth of infection is good, but I think there is still a need for some
information on how these infections will be diagnosed. Especially the definition of
superficial incisional SSI is a problem. It will be an advantage if the authors have given a
clear definition before the start of the study. See for instance
http://www.bmj.com/content/329/7468/720
Author’s response:
We agree with the reviewer on the importance of a clear definition of SSI as different
definition criteria have been shown to result in different occurrence rates of SSI (Wilson et
al, BMJ 2004; 329). We have used the following clinical criteria added in the text (added
text underlined). These criteria do not strictly follow the CDC, NINSS or the ASEPSIS
criteria, but are derived mainly from the CDC classification.
“Post-intervention data
Surgical treatment
 Clinical wound infection (surgical site infection, SSI) occurring within
30 days after the operative procedure diagnosed by a surgeon or
positive bacterial culture
o Superficial incisional SSI – infection involves only skin and
subcutaneous tissue of incision presenting with at least one
of the following signs or symptoms of infection
 purulent drainage from the superficial incision
 pain or tenderness
 localized swelling
 redness or heat
o Deep incisional SSI – infection involves deep tissues, such
as fascial and muscle layers
 purulent drainage from the deep incision
 deep incision is deliberately opened by a surgeon in
case of fever and localized pain or the incision
spontaneously dehisces
o Organ/space SSI – infection involves any part of the anatomy
in organs and spaces other than the incision, which was
opened or manipulated during the operation “
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests