Dilute povidone-iodine irrigation versus normal saline irrigation in preventing surgical site infection after appendectomy for perforated appendicitis

ISRCTN	ISRCTN10376975
DOI	https://doi.org/10.1186/ISRCTN10376975
Sponsor	University of Port Harcourt Teaching Hospital
Funder	University of Port Harcourt Teaching Hospital

Submission date: 21/03/2026
Registration date: 04/04/2026
Last edited: 07/05/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration

Contact information

Dr Emmanuel Afolabi
Principal investigator, Scientific, Public

Department of Surgery, University of Port Harcourt Teaching Hospital, East-West Road, Alakahia, Port Harcourt
Port Harcourt, Rivers State
500102
Nigeria

ORCID ID	0009-0002-6833-1220
Phone	+2348060553917
Email	drdareafolabi2001@yahoo.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Treatment
Scientific title	Dilute povidone-iodine irrigation versus normal saline irrigation in preventing surgical site infection after appendectomy for perforated appendicitis: a randomized controlled trial
Study acronym	POVI-SSI
Study objectives	This study aims to compare two commonly used solutions, dilute povidone-iodine and normal saline, for cleaning the surgical wound during appendectomy in patients with perforated appendicitis. Surgical site infection is a common complication after this type of surgery, especially in severe cases. Patients were randomly assigned to receive either povidone-iodine or normal saline irrigation during surgery. The study evaluates which method is more effective in reducing wound infections and improving patient outcomes after surgery.
Ethics approval(s)	Approved 27/02/2017, The Ethics and Research Committee at the University of Port Harcourt Teaching Hospital (UPTH) (East-West Road, Port Harcourt, 500102, Nigeria; -; info@upthng.com), ref: UPTH/ADM/90/S.II/VOL.XI/374
Health condition(s) or problem(s) studied	Perforated appendicitis requiring appendectomy
Intervention	Randomisation was performed using a computer-generated random sequence with allocation concealment via sealed opaque envelopes. Participants were randomly assigned to one of two groups: Group A received dilute povidone-iodine irrigation of the surgical wound before closure, while Group B received normal saline irrigation before wound closure during appendectomy for perforated appendicitis.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Surgical site infection within 30 days following appendectomy measured using clinical assessment data, based on standard diagnostic criteria, including the presence of purulent discharge, wound erythema, swelling, tenderness, or wound dehiscence at one timepoint at the end of the trial
Key secondary outcome measure(s)	Length of hospital stay and postoperative complications during the hospital stay and within 30 days postoperatively measured using data recording the number of days from surgery to discharge, and clinical assessment data, based on the occurrence of any adverse events following surgery, at one timepoint at the end of the trial
Completion date	31/12/2021

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	120
Total final enrolment	120
Key inclusion criteria	1. Adult patients (≥18 years) 2. Diagnosed with perforated appendicitis, undergoing emergency appendectomy 3. Provided informed consent
Key exclusion criteria	1. Patients with non-perforated appendicitis 2. Those with previous abdominal surgery 3. Patients with significant immunosuppression or severe comorbidities 4. Those who did not provide informed consent
Date of first enrolment	01/12/2019
Date of final enrolment	31/12/2020

Locations

Countries of recruitment

Nigeria

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file			07/05/2026	No	No

Additional files

ISRCTN10376975 Protocol.pdf: Protocol file

Editorial Notes

07/05/2026: Uploaded protocol (not peer-reviewed) as an additional file.
01/04/2026: Study’s existence confirmed by the University of Port Harcourt Teaching Hospital Ethical Committee and the Research Ethics Group of the Centre for Medical Research and Training College of Health Sciences, University of Port Harcourt, Nigeria.