Impact of WHO's Surgical Safety Checklist-Based Program on Cleft-lip and Palate Repair Outcomes in LMICs-The CLEAN CLEFT Program.

Abstract

Background: "Clean Cleft" (CC) is an adaptation of the Lifebox Clean Cut program, designed to reduce surgical site infections (SSIs) in cleft lip and palate repairs. It focuses on 6 key processes: hand and site decontamination, surgical linen integrity, instrument sterility, timely antibiotic use, gauze counting, and WHO Surgical Safety Checklist compliance. The study explores CC's effectiveness in reducing infections, other complications, and enhancing early recovery.

Methods: CC was piloted in 2 Ethiopian hospitals and 1 in Côte d'Ivoire, the primary public cleft care centers in each country. Baseline data were collected through direct observation in the operating room, with patients monitored postoperatively for infections and complications through daily ward visits and follow-up calls or clinic visits at 30 days. Post-intervention data were collected for 5 months. Data was captured in DHIS2 software and analyzed using SPSS version 26.

Results: The program enrolled 275 patients, with 156 during baseline and 119 post-implementation. Complications significantly dropped from 21.7% to 8.7% (P = .008), a 60% decrease. SSI rates fell from 18.1% to 8.0% (P = .03), while palatal fistulas decreased from 13.0% to 6.1% (P = .1) and wound dehiscence from 18.0% to 8.0% (P = .03). Adherence to perioperative standards improved, except for hand and skin preparation while pain management remained effective throughout the program.

Conclusion: CC improved perioperative practices, significantly reducing infections, palatal fistulas, and wound dehiscence, supporting the broader program expansion to any subspecialty.