Skip to main content
. 2013 Sep 5;2013(9):CD006214. doi: 10.1002/14651858.CD006214.pub4

Sondergaard 1982.

Methods RCT
 Setting: hospital inpatient and outpatient, Denmark
Participants n = 28 started the trial and 22 completed the trial
 (A) 10
 (B) 12
 Numbers of men and women not reported
 Participants ages not reported
 Consent was not reported but patients were provided with oral and written objectives of the study
 Study was in accordance with the Helsinki declaration, 1975
Inclusion criteria: patients with suppurating infected surgical wounds involving subcutaneous tissue
Exclusion criteria: patients prescribed systemic steroid therapy; patients receiving another local wound intervention; patients with substantial wound revision and if there was peritoneal communication
Interventions A microbiological swab was taken from the bottom of each wound at the start of the trial and on every 7th day until the wound was clean; this was to document the bacterial flora to register any favourable influences of the dressings
(A) Wound irrigated with saline; dextranomer beads made into a paste and applied to the wound; covered with a sterile compress; dressing changed at least daily and before it became fully saturated
 (B) Dressing soaked in 0.1% chloramine solution; covered with a sterile compress; changed once daily and 2 or 3 times if saturated; dressings changed by senior registrars; trial authors undertook assessment of the wounds
Outcomes Primary outcomes:
(1) Time to clean wound bed (reported as the median: mean, SD or SEM not reported for any of the results):
 (A) 6 days
 (B) 5 days
 (2) Time until the wound was clinically assessed as ready for outpatient treatment (median):
 (A) 9 days
 (B) 7 days
 (3) Time to wound healing (median):
 (A) 27 days
 (B) 20 days
 Observed results were compared and assessed using the Mann‐Whitney U‐test; no significant difference reported; detailed data and statistics not included
Secondary outcomes:
(1) Patient satisfaction: dressing changes were less painful in group A; no data or statistics presented
 (2) Rate of infection: not reported; results of microbiological wound swabs not reported
 (3) Quality of life: not reported
 (4) Length of hospital stay: not reported
 (5) Cost‐effectiveness:
 (A) Approximately 123 Danish Kroner per dressing change
 (B) Approximately 1.50 Danish Kroner per dressing change
 Cost analysis not presented
 (6) Adverse events: 4 patients excluded from group A: 2 patients died, cause of death not reported; 1 had peritoneal communication; in 1 the wound was too undermined for application of the paste; 2 excluded from group B: 1 had heavy growth of bacteria and the dressing was changed to acetic alumina; 1 had a total wound rupture
Notes The trial authors did observe more granulation tissue; less irritation and less pain on dressing changes with the dextranomer dressing. Blinding of assessors (trial authors) is not reported. The original paper was in German and the data were extracted after being translated into English.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Although the trial reports that the patients were allocated by a "random sequence generated in blocks of 4" (p1523) no further information is given regarding the blocks of 4. However, this is judged to be adequate sequence generation.
Allocation concealment (selection bias) Low risk "...sealed, numbered envelopes" (p1523) is reported to conceal allocation, however it is not stated if these envelopes were opaque. However, this is judged to be adequate allocation concealment.
Blinding (performance bias and detection bias) 
 Participants and personnel Unclear risk It is not stated if the participants were blinded however this would be unlikely to influence findings. It is not stated if the personnel involved in redressing the wounds (senior registrars) were blinded or not
Blinding (performance bias and detection bias) 
 Outcome assessors Unclear risk It is unclear from the trial if the assessors (the study authors) were blinded
Incomplete outcome data (attrition bias) 
 All outcomes High risk A total of 6 patients were excluded from the study (2 from the chloramine and 4 from the Debrisan), a rationale for the exclusions is given and exclusions are mentioned in the presented in results tables. It is not clear if these were also excluded from the final analysis. Also, the dropout rate was 21% (> 10%) and hence judged to be unacceptable.
Selective reporting (reporting bias) Unclear risk No study protocol is available. No study aims or outcomes are stated in the paper. Results reported include: number of days from start of treatment to a clean wound; number of days until wound assessed as ready for outpatient treatment; number of days until wound healed. It is apparent that the intention was also to examine the number of daily wound dressing changes required but this was abandoned due to insufficient recording (p1524)